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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After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.
The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.
The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.
The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.
Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.