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By PharmaCompass
2023-08-31
Impressions: 1065
After a year of signing the landmark Inflation Reduction Act (IRA), this week the US government released the long-awaited list of 10 prescription medications that will now be open to initial price negotiations under the US Medicare health program.
In approvals, Bristol Myers Squibb’s Reblozyl received US FDA (Food and Drug Administration) approval for first-line treatment of anemia in patients diagnosed with myelodysplastic syndromes (MDS) who may require regular RBC transfusions. Additionally, Sandoz’s biosimilar for BMS’ multiple sclerosis (MS) drug Tysabri also bagged FDA approval.
In trial news, Novo Nordisk’s Wegovy injection resulted in significant reductions in heart failure in obese adults in a late-stage trial.
In regulatory news, FDA issued a Form 483 to Gland Pharma with two observations after a pre-market inspection of its Pashamylaram facility in Hyderabad, India. The US agency rejected Outlook Therapeutics’ experimental eye disease drug due to manufacturing issues observed during pre-approval inspections. And, FDA issued a warning letter to California-based eye drop manufacturer K.C. Pharmaceuticals, citing significant violations of current good manufacturing practices (cGMP).
US releases list of first drug for price negotiations under Medicare
Biden administration has released the long-awaited list of 10 prescription medications that will now be open to initial price negotiations under the US Medicare health program that caters to 66 million Americans, predominantly above the age of 65. The list comprises several prominent medications, such as BMS and Pfizer’s widely sold blood thinner Eliquis, and its rival med from Johnson & Johnson Xarelto, Merck’s diabetes drug Januvia, and AbbVie’s treatment for leukemia Imbruvica. Other medicines chosen for negotiations include Amgen’s rheumatoid arthritis drug Enbrel, Boehringer Ingelheim and Eli Lilly’s diabetes medication, Jardiance, J&J’s solution for arthritis and Crohn’s disease, Stelara, as well as insulin provided by Novo Nordisk. The revised prices of these drugs will become effective in 2026. With this initiative, the US government hopes to save US$ 25 billion annually on pharmaceutical expenses by 2031.
Novo’s Wegovy reduces heart failure in obese patients in late-stage study
Novo announced encouraging outcomes from a late-stage study involving their weekly Wegovy injection that showed significant reductions in heart failure in obese adults. The trial compared Wegovy’s efficacy to a placebo in patients dealing with both obesity and heart failure with preserved ejection fraction (HFpEF) for one year. Earlier this month, in a separate late-stage study, Wegovy cut the risk of heart attacks and strokes by 20 percent.
Catalent’s Indiana plant to make Novo’s Wegovy: Catalent’s plant in Bloomington, Indiana, became the third facility to fill injection pens for Novo Nordisk’s Wegovy as part of the two companies’ expanded supply agreement, according to Reuters. Catalent’s factory in Brussels is the first site, with Thermo Fischer’s North Carolina facility joining it earlier this month. In response to surging demand in the US, the Danish drugmaker is putting concerted efforts to ramp up the drug’s production.
Novo acquires Embark Biotech for its diabetes, obesity treatments: Novo Nordisk has bought Embark Biotech for €15 million upfront (US$ 16.3 million) and has agreed to pay up to €456 million (US$ 494.2 million) in milestones to maintain its dominance in the lucrative field of obesity and diabetes. The companies agreed to a three-year collaborative effort in research and development aimed at discovering and creating innovative pharmaceuticals for the treatment of obesity and associated conditions.
Lilly’s diabetes drug to face shortage in Europe: The European Medicines Agency (EMA) has announced shortage of Trulicity, Eli Lilly’s sought-after diabetes medication, throughout September. Austria, Finland, Greece, Poland, and Sweden are currently affected with a shortage of Trulicity, with Denmark and Norway also expected to experience temporary supply gaps.
FDA expands use of BMS’ anemia med; Sandoz’s Tysabri biosimilar bags approval
Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) received FDA approval as first-line treatment of anemia without prior erythropoiesis stimulating agent (ESA) usage among adult patients diagnosed with myelodysplastic syndromes (MDS) with very low-to intermediate-risk MDS who may require regular red blood cell (RBC) transfusions. BMS had gained the drug through the acquisition of Celgene in 2019 and marks Reblozyl’s third US approval in an anemia subgroup. The company targets US$ 4 billion in peak sales for the drug.
FDA also approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster multiple sclerosis (MS) treatment Tysabri, developed by Polpharma Biologics. Tyruko is the first and only biosimilar approved as a mono-therapy to treat all indications covered by reference medicine Tysabri for relapsing forms of MS. Tysabri accounted for nearly 25 percent of Biogen’s revenue in 2022 by generating US$ 2.03 billion in sales.
MHRA approves first seven-minute cancer jab: The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval to Roche’s Tecentriq SC (atezolizumab) injection, making it the first subcutaneous anti-PD-(L)1 cancer immunotherapy accessible to patients in the United Kingdom. Tecentriq’s SC injection utilizes Halozyme’s ENHANZE drug delivery technology, enabling an administration process that takes around seven minutes, in contrast to the 30 to 60 minutes required for intravenous infusion. Tecentriq’s subcutaneous variant will be accessible to eligible patients in Great Britain suffering with specific forms of lung, bladder, breast, and liver cancer.
Pfizer’s RSV vaccine authorized in Europe: The European Commission (EC) has authorized Pfizer’s Abrysvo, a vaccine for respiratory syncytial virus (RSV) to protect newborns through maternal immunization during pregnancy. It has also been approved for adults 60 years of age and older in the European Union.
The European Union has also recommended authorizing an updated Covid vaccine from Pfizer and BioNTech which targets the dominant XBB.1.5 variant of Omicron.
FDA issues Form 483 to Gland’s India plant; rejects Outlook’s experimental eye drug
FDA has issued a Form 483 with two observations to Gland Pharma after a pre-market inspection of its Pashamylaram facility in Hyderabad, India, conducted from August 23 to 26. The observations reported pertained to the ANDA filed for the product to be manufactured in a pen device. There was no data integrity observation.
The US agency has also declined to approve Outlook Therapeutics’ experimental eye disease drug, in part due to manufacturing issues observed during pre-approval inspections. Moreover, FDA has issued a warning letter to California-based eye drop manufacturer K.C. Pharmaceuticals, citing significant violations of current good manufacturing practices (cGMPs).
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