FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
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The regulator has approved Eyenovia and Formosa’s ophthalmic clobetasol propionate solution to ease eye inflammation and pain after surgery, with a potential $1.3 billion market.
Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.
On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
Johnson & Johnson’s anti-BCMA antibody can now be dosed once every two weeks in relapsed or refractory multiple myeloma patients who have achieved and maintained complete response for at least six months.
The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.
Eicos Sciences’ injectable vasodilator Aurlumyn is the first FDA-approved medication for severe frostbite to reduce the risk of finger or toe amputation by opening blood vessels and preventing clotting.
Approved in combination with three chemotherapies, Onivyde is the first new frontline treatment option in more than 10 years for adults living with metastatic pancreatic adenocarcinoma.
The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss BMS and J&J applications for their CAR T-cell therapies Abecma and Carvykti, respectively.
The new FDA-approved manufacturing process for Kite’s CAR-T cell therapy Yescarta will allow a 14-day turnaround compared to 16 days, the company announced on Tuesday.