The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US Food and Drug Administration (FDA) compared to the same period last year.FDA’s Center for Drug Evaluation
and Research (CDER) approved 21 drugs in H1 2024, reflecting a 19 percent decrease from the 26 approvals granted in H1 2023. Of them, 81 percent (17) were first-in-class drugs (therapies that use a new and unique mechanism of action), while small molecules made up for 67 percent (14) of the total drugs approved.Similarly, the Center for Biologics
Evaluation and Research (CBER) granted approvals to only eight biologics, as compared to 10 in H1 2023.Health Canada also saw a drop in drug approvals as only 10 drugs were okayed in H1 2024, as opposed to 13 approvals in H1 2023.The European Medicines Agency (EMA) saw a marginal rise in drug authorizations at 15 for H1 2024 as compared to 14 approvals in H1 2023. Interestingly, the EMA also saw a surge in pending decisions (applications under review) — from two in H1 2023 to 14 in H1 2024.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available)Merck, Madrigal, Verona bag approvals for breakthrough meds; Lilly’s donanemab okayedThe first half saw some closely watched drugs win regulatory
approvals. FDA approved a breakthrough therapy from Merck — Winrevair (sotatercept) — that treats adults with hypertension caused by the constriction
of arteries in the lungs, known as pulmonary arterial hypertension (PAH).Merck had acquired Winrevair
through its US$ 11.5 billion acquisition of Acceleron Pharma in 2021. The therapy is set
to generate nearly US$ 3 billion in global peak sales by 2028. Another breakthrough therapy approved in H1 2024 is Madrigal’s Rezdiffra (resmetirom), the first FDA-approved treatment for adults with the common fatty liver disease — nonalcoholic steatohepatitis (NASH). Rezdiffra is expected to touch sales of US$ 2.1 billion by 2028.The agency also approved the first maintenance treatment for chronic obstructive pulmonary disease (COPD) in over 20 years — Verona’s Ohtuvayre. The drug has a novel
mechanism of action and is the first inhaled maintenance treatment
for COPD. Approved in June by the FDA, Ohtuvayre is forecast to bring in global
sales of US$ 1.5 billion by 2030.The approval of Eli Lilly’s donanemab was surprisingly delayed, and finally came through on
July 2 after an FDA advisory committee voted unanimously in favor of its
benefits outweighing its risks. To be sold as
Kinsula, the
Alzheimer's drug is estimated to bring in US$ 2.2 billion in sales by 2028.Across the pond, EMA approved Novo Nordisk’s weekly insulin injection Awiqli (insulin icodec). The replacement insulin in Awiqli acts in the same way as the body’s own insulin and helps glucose enter cells from the blood. Meanwhile, FDA rejected this once-a-week insulin
earlier this month and has requested information related to the manufacturing
process.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) ImmunityBio, Geron, Day One
win approvals for their oncology drugsIn what marks the first approval for ImmunityBio, FDA greenlit Anktiva
(nogapendekin alfa inbakicept-pmln) as part of a combination therapy to treat a type of bladder cancer. Anktiva is a next-generation immunotherapy that creates long-term immunity by activating the so-called natural killer (NK) cells and T-cells. It will compete with Merck’s Keytruda. Anktiva’s yearly sales by 2030 are expected to be around
US$ 1.7 billion.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) got the go-ahead from the FDA as the
treatment for adult patients with unresectable or metastatic esophageal
squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Tevimbra’s 2028 global sales are forecast to bring in US$ 1.6 billion.FDA signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent
anemia in patients with low- to
intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This was Geron’s maiden approval and Rytelo is expected to bring in US$ 1.3 billion by 2030.Day One Biopharmaceuticals’ Ojemda (tovorafenib) was granted FDA’s accelerated approval to treat certain types of pediatric brain
cancer. This is the first FDA approval of a systemic therapy for treating
what is the most common form of childhood brain tumor, including fusions.
Ojemda is forecast to bring in US$ 1 billion in sales by 2030.FDA granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adults in advanced stages of small cell lung
cancer (SCLC) that has proven to be hard to treat or has worsened
despite platinum-based chemotherapy. Imdelltra is expected to bring in
annual sales of US$ 975 million by 2030.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Infectious disease drugs from
Basilea, Merck, rare disease med from Ipsen bag
approvalsAfter oncology, infections and infectious diseases, and rare
diseases were the two therapeutic areas that saw the second and third most approvals,
respectively. FDA approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril
sodium for injection), an antibiotic for bacterial infections
including multidrug-resistant strains.The US agency also approved Merck’s next-generation vaccine designed to protect adults from pneumococcus bacteria that causes serious illnesses and pneumonia. The jab, known as Capvaxive, helped produce an immune response against all 21 variations (serotypes) of the bacteria that it targeted. These 21 strains account for about 85 percent of invasive pneumococcal disease cases in adults aged 65 and above. FDA also approved Moderna’s mRESVIA, a messenger RNA-based (mRNA) respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and
older from lower respiratory tract disease caused by the syncytial
virus. This is the first non-Covid mRNA vaccine
to be approved in the US.The agency granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat primary
biliary cholangitis (PBC), a rare liver disease. This is the first new
medicine approved in nearly a decade for the treatment of PBC. Orchard Therapeutics’ Lenmeldy secured FDA approval to become the first gene therapy in the US for a rare pediatric disorder, known as metachromatic
leukodystrophy (MLD). The debilitating hereditary disease affects the
brain and the nervous system and causes loss of cognitive and motor functions
and early death.View New Drug Approvals in H1 2024 with Estimated Sales (Free Excel Available) Our viewThe increased momentum of drug approvals witnessed after the pandemic appears to have slowed down, but what’s encouraging is the increase in first-in-class therapies, cancer drugs and promising new treatment options for a range of conditions such as PAH, NASH, and COPD.The
second half has already kicked off with the approval of Lilly’s donanemab. And there are several pathbreaking drugs likely to be approved soon, such as Karuna Therapeutics’ schizophrenia drug KarXT and BridgeBio’s heart drug acoramidis. There is every possibility that new drug approvals will spring back up in H2 2024.
Impressions: 1510
Every year, the list of top pharmaceutical products and companies by sales sees some churn. But the year 2021 was a lot different — it saw the pharma industry landscape change dramatically. It was a
year when the industry was busy developing vaccines and therapies so that the
world could recover from the Covid-19 pandemic. And this resulted in many
drugmakers raking in billions of dollars in sales.
As a result,
the top company of 2020 in terms
of pharmaceutical sales — Roche — slipped to the number five spot, while Pfizer, which was at number eight in 2020 after
spinning off its generic business, moved up to the number one slot.
The year
proved to be a good one for pharmaceutical companies.
Interestingly, last year none of the top 20 pharmaceutical companies saw a decline in
their revenue.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Pfizer’s Comirnaty steals the show
The
company that reaped the maximum gains from its Covid vaccine was Pfizer.
Comirnaty (tozinameran) was the top selling pharmaceutical
product of 2021, posting global revenues of US$ 36.8 billion. This
messenger-RNA Covid-19 vaccine, developed along with its German partner BioNTech, catapulted Pfizer to the slot of the top company by sales in 2021. Pfizer’s global topline grew from US$ 41.7 billion in 2020 to US$ 81.3 billion in 2021.
In
2020, Pfizer was at
number eight, behind Roche, Novartis, GSK, AbbVie, J&J, Merck and BMS. In 2021, it took a lead of billions of dollars on all these companies. The second largest drug company by sales — AbbVie — was way down at US$ 56.1 billion in global revenues. In fact, Comirnaty has
become the fastest-selling drug in the history of the pharmaceutical
industry.
Back in
December 2020, when both Comirnaty and Moderna’s Spikevax had bagged the US Food and Drug Administration’s emergency use authorization (EUA), there was a lot of uncertainty around how the promised doses would be delivered across the world. But both Comirnaty and Spikevax have proven to be a resounding success. Spikevax emerged as the third largest selling pharmaceutical product of 2021, bringing in US$ 17.7 billion for Moderna.
Analysts
expect both Pfizer-BioNTech and Moderna to sell even more vaccines in
2022. The reasons are manifold. First, SARS-CoV-2 is able to mutate often, and
is unlikely to be eradicated in the near future, creating a need for booster
shots. Second, the younger age groups are still to get vaccinated.
Along with
Comirnaty, Pfizer is battling Covid-19 with its antiviral pill, Paxlovid. Though the sales of Paxlovid have nosedived of late, Pfizer expects
Comirnaty and Paxlovid to help the New York-headquartered drug behemoth achieve US$ 100 billion
in 2022 revenues.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
AbbVie
moves up, sans Covid product; Roche slips to number five
With no
Covid-19 related products, AbbVie did fairly well in 2021 — it moved up from the number four spot in 2020 to number two position, thanks to its Allergan acquisition, cash cow Humira (adalimumab), the continued success of its
cancer drug Imbruvica (ibrutinib) and an increase in sale of its psoriasis treatment Skyrizi (risankizumab) by a whopping 85 percent in 2021. Humira brought in sales of US$ 21.2 billion for AbbVie in 2021. However, things may change soon, with biosimilars of Humira slated to enter the market in 2023. The years 2022 and 2023 are likely to be transition years for AbbVie, as it works to build the market for its Humira successors — Rinvoq and Skyrizi.
Roche
emerged as a big loser in 2021, as several copycats of its blockbuster drugs
hit the market. Copycats to Roche’s three blockbuster cancer drugs—Avastin, Herceptin and Rituxan—eroded US$ 4.9 billion (CHF 4.73 billion) from the company’s sales in 2021. A large chunk
of growth for Roche came from its multiple sclerosis med Ocrevus, hemophilia drug Hemlibra, inflammatory disease therapy Actemra and PD-L1 inhibitor Tecentriq. The pandemic resulted in
lower-than-expected sales of Ocrevus (ocrelizumab) due to fears around its
immunosuppressive effects.
Like Roche, Novartis also slipped last year. It fell from
number two in 2020 to the number four slot in 2021. Essentially, Novartis is
struggling with a relatively lackluster pipeline. It had sold its 33 percent stake in Roche last
year for US$ 20.7 billion. It plans to use that sum for acquisitions in order
to beef up its pipeline. The Swiss drugmaker has also drawn up a restructuring
plan that includes layoffs of thousands of employees.
Before the
pandemic, Merck’s Keytruda was touted as the drug that would overtake
Humira at the top in 2024. The checkpoint inhibitor has continued to grow
impressively, adding new indications and treatment lines. Keytruda is now used
in close to 40 indications. With US$ 17.2 billion in sales, Keytruda emerged as
the fourth largest selling drug of 2022.
Overall
though, Merck slipped from number six to the number eight slot. This was due to
the fact that Merck had spun out its women’s
health, biosimilars and established brands businesses into Organon. However, its Covid-19 antiviral pill — Molnupiravir — was able to compensate for the lost revenue. Though the FDA is yet to grant the drug a full approval (it bagged an EUA in December 2021), advance sales agreements helped it rack up US$ 952 million in sales in the fourth quarter.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
BMS moves
up with Eliquis, Revlimid; J&J lands at number three
Bristol Myers Squibb (BMS) moved up from number seven in 2020 to number six, thanks to two of its drugs that made it to top 10 — anticoagulant Eliquis at number five and oncology drug Revlimid at number six. However, Revlimid will soon face competition — four generic companies now have the approval to sell their versions of Revlimid (lenalidomide) after March 2022. Revlimid
sales are expected to drop from US$ 12.9 billion to just US$ 2.06 billion in
2026.
BMS posted
US$ 46.4 billion in global revenues, a nine percent increase from US$ 42.5
billion reported in 2020. In immuno-oncology, Opdivo
brought in US$ 7.52
billion in sales, while Yervoy drew in sales of US$ 2 billion
(an increase of 20 percent).
J&J’s pharma division brought in US$ 52.1 billion in revenues
last year, an increase of 14 percent over its revenues of US$ 45.6 billion
posted in 2020. Drugs like Darzalex (for multiple myeloma), Stelara and its Covid-19 vaccine brought in growth during 2021,
helping J&J move up from number five to the number three slot. J&J’s Covid-19 vaccine brought in US$ 2.4 billion in
sales.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
GSK bags
approval for shingles vaccine; Takeda suffers setbacks
GlaxoSmithKline (GSK) slipped four places — from number three in 2020 to number seven in 2021. Though GSK did not have a drug in the top 10, sales of GSK and Vir Biotechnology’s Covid-19 antibody treatment
sotrovimab helped produce a seven percent increase in its 2021 revenue. The British drugmaker also bagged a critical FDA approval — its vaccine to prevent shingles (herpes zoster), Shingrix, bagged the agency’s nod in July. GSK hopes to double the sales of Shingrix by 2026.
GSK is also undergoing a major transformation, and plans to demerge its consumer health unit this year. The unit generated revenues of £9.6 billion (US$ 13 billion) last year, and GSK sees the demerger as a necessary step to fuel growth through the development of new vaccines and specialty medicines.
Sanofi managed to retain its ninth slot, even as
its global turnover increased from US$ 39.3 billion (Euro 36.04 billion) to US$
41.6 billion (Euro 37.76 billion). It snapped up Kymab, Tidal Therapeutics, Translate Bio, Kadmon Holdings, Origimm Biotechnology and Amunix in deals that bolstered its presence in immunology, immuno-oncology and vaccines. Dealmaking is on the French drugmaker’s menu for 2022 and beyond, Sanofi’s CFO said at this year’s virtual JP Morgan Healthcare Conference.
AstraZeneca’s global revenues grew from US$ 26.6 billion in 2020 to US$ 37.4 billion in 2021. However, its rank fell from nine in 2020 to 10 in 2021.
AstraZeneca
wrapped up the US$ 39 billion acquisition of Alexion in July 2021. Alexion’s rare disease franchise—led by C5 inhibitors Soliris and Ultomiris—added an extra US$ 3.1 billion to Astra’s top line last year.
Takeda suffered several clinical and regulatory setbacks in 2021, which it labeled as an “inflection year.” For Gilead, sales of its Covid-19 antiviral Veklury brought in US$ 5.6 billion last year,
helping its revenues grow by 11 percent.
View Our Interactive Dashboard on Top Drugs by Sales in 2021 (Free Excel Available)
Our view
If anything,
the pandemic has taught us that change is the only constant. It has also taught
us that products can become blockbusters in a matter of a few months.
The industry
landscape continues to change. On the one hand, we are seeing people scrambling
to get Covid vaccines and booster shots, on the other hand, the FDA has limited the use of monoclonal antibodies, such as Eli Lilly’s bamlanivimab and etesevimab and
Regeneron’s REGEN-COV (casirivimab and
imdevimab), in treating Covid caused by the Omicron variant. The FDA has also pulled the authorization
granted to GSK and Vir Biotechnology’s antibody therapy this month,
citing data that suggested it was unlikely to be effective against the dominant
Omicron sub-variant.
And last
week, there was news that demand for Pfizer’s
antiviral pill Paxlovid has remained unexpectedly low. The supply
of Paxlovid, which reduced hospitalizations or deaths in high-risk patients by
around 90 percent in a clinical trial, has far outstripped demand in many
countries like the US, the UK and South Korea.
Though Pfizer is hopeful of crossing US$ 100 billion in revenue this
year, much depends on how the pandemic pans out and what new research has to
say about the novel coronavirus. A lot will change once the pandemic becomes endemic.
The first four months of 2022 tell us that vaccines like Comirnaty and Spikevax
will continue to perform well.
But two years down the line, our charts could look very different.
Impressions: 8103