FDA Strikes More Than 40 Drugs Approvals in 2014

FDA Strikes More Than 40 Drugs Approvals In 2014

Unless you are like Voltaire and think that “The art of medicine consists of amusing patients while nature cures the disease”, you will be thrilled with the new drugs approval (NDAs) list of the FDA: about 40 new drugs in 10 therapeutic areas! It has been 18 years since the FDA approved so many new drugs, so let’s quickly take a tour at the Olympic podium:

OLYMPIC PODIUM

The golden medal comes to AstraZeneca with 4 NDAs: Farxiga (diabetes), Movantik (constipation), Lynparza (ovarian cancer) and Myalept (lipodystrophy, also called fat reduction, which is common in patients with HIV and AIDS).

Then come the silver medals with 3 NDAs each:

Biogen Idec with Alprolix (hemophilia B), Eloctate (hemophilia A), Plegridy (multiple sclerosis).
Lilly with Cyramza (gastric cancer), Jardiance (diabetes), Trulicity (diabetes).
Merck&Co with Zontivity (coronary artery disease), Belsomra (insomnia), Keytruda (melanoma).

And the bronze medals with 2 NDAs each:

Boehringer-Ingelheim with Striverdi Respimat (chronic obstructive pulmonary disease), Ofev (idiopathic pulmonary fibrosis).
Cubist with Sivextro (skin infection), Zerbaxa (urinary and abdominal infections).
Gilead with Zydelig (leukemia), Harvoni (hepatitis C –“first combination pill approved to treat chronic hepatitis C virus genotype 1 infection and the first approved regimen that does not require administration with interferon or ribavirin”).
Novartis with Xtoro (acute otitis externa), Zykadia (lung cancer).

THERAPEUTIC AREAS

In terms of therapeutic areas, infectious diseases come first with 27% of the NDAs, followed by cancer with 18% and then rare diseases with 11% according to Forbes. Knowing that a disease is classified as ‘rare’ when it affects 200,000 people maximum in the US, the pharmaceutical industry and the FDA have done a fantastic job because overall it is 25 millions American whom are concerned by orphan diseases. And how many more around the world?
According to EvaluatePharma, in 2020 orphan drugs are expected to account for 19% of the total share of prescription drug sales excluding generics, reaching $176 billion in annual sales in America alone.

Here are the main NDAs 2014 for rare diseases:

Amgen with Blincyto (Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia- leads to cancer).
Anacor with Kerydin (fungal infection).
BioCryst with Rapivab (influenza- infectious disease caused by the influenza virus).
Biomarin with Vimizim (Morquio A syndrome- the body is missing or doesn't have enough of a substance needed to break down long chains of sugar molecules).
Boehringer-Ingelheim with Ofev (idiopathic pulmonary fibrosis).
Chelsea with Northera (neurogenetic orthostatic hypotension- often associated with Parkinson’s disease).
Hoffman la Roche with Esbriet (idiopathic pulmonary fibrosis).
Johnson & Johnson with Sylvant (multicentric Castleman’s disease- involves hyper activation of the immune system).
Paladin with Impavido (leishmaniasis- disease caused by protozoan parasites).
Sanofi with Cerdelga (Gaucher’s disease- genetic disease in which fatty substance accumulate in cells and certain organs).
Spectrum with Beleodaq (non-Hodgkin lymphoma- group of blood cancers that includes any kind of lymphoma except Hodgkin's lymphomas).
Takeda with Entyvio (ulcerative colitis ; Crohn’s disease- inflammatory disease that affects any part of the gastrointestinal tract from mouth to anus)
Valeant with Jublia (fungal infection).
Vanda with Hetlioz (non stop 24 hour sleep wake disorder).

The huge impact after the release of the 2014 NDAs list was the pharma exchange-traded funds flared up (Nasdaq Biotechnology Index and S&P 500 Health Care Index 34 percent and 23 percent respectively.
However, finance is not everything, as we have all learned during the 2008 financial crisis, and NDAs are not the only conditions for a new strategy to success anymore, as proven by a lot of pharmaceutical companies in the past years who haven’t achieved enough revenues despite NDAs.

It seems that pricing is going to be key as competition is becoming fiercer. Look at the 2014 NDAs batch for anti bacterial drugs to treat skin infections; 3 brand new drugs for this year only.

Cubist with Sivextro
Durata with Dalvance
The Medecine Companies with Orbactiv

Same for the idiopathic pulmonary fibrosis as we just saw in the rare diseases approval list above: 2 NDAs for 2014. According to Fierce Pharma, there are 8 therapeutic areas where competition is going to be even fiercer in the future: hepatitis C, diabetes, cholesterol, hemophilia, hemo-oncology, psoriasis, melanoma and obesity.

And it is not like patents are not going to continue dropping; generics represent now more than 40% of the products sales. Moreover, premium prices following NDAs have been implicating confrontations with insurers and governments in regards to diabetes and respiratory drugs in the past.

Therefore, new tactics have to be found!

AbbVie offered their new anti hepatitis C drug, Viekira Pak, at a discount price to Express Script (the largest pharmacy benefit management organization in the United States) for an exclusive distribution. Even if Viekira Pak is said to be a less convenient dosing regiment when compared to Gilead’s anti hepatitis C drug (Sovaldi), the deal was closed as Sovaldi’s premium price actually chocked the payers. It is a perfect move for AbbVie, who just lost their patent on one of their main drug: Humira (rheumatoid arthritis).

Biotech are said to be an excellent area for successful strategy as well.

If there is more success at R&D projects (as it looks to be the case in the biotech field) then R&D department cost less and the overall financial risk should be lowered.

Here are the main NDAs 2014 for biotech/ cancer:

Baxter with Obizur (hemophilia).
Biogen Idec with Plegridy (multiple sclerosis), and Alprolix and Eloctate (hemophilia).
Celgene with Otezla (psoriasis)
Gilead with Zydelig (anti-cancer treatment).
Helsinn with Akynzeo (emesis- prevent nausea and vomiting caused by cancer drug treatment).
Salix with Ruconest and Pfizer with Trumenba (meningitides type B).

Bristol-Myers Squibb with Opdivo (melanoma) and Merck & Co with Keytruda (melanoma as well), which work by blocking a protein called Programmed Death receptor (PD-1), are the first in a coming wave of immunotherapies and are said to have the potential of generating more than 30 million USD/ year.

So in case all these new strategies don’t work and definitely become a financial matter only instead of a medical focus to help the world to live a little better, don’t forget to “always laugh when you can, it is cheap medicine” as George Gordon Byron liked to advise.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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