Approvals
The FDA approved Eli Lilly’s orforglipron—to be known as Foundayo—on Wednesday, officially igniting what analysts believe will be a fierce rivalry with Novo Nordisk’s oral Wegovy.
Biogen, Eli Lilly, Merck and Novartis spent more than $20 billion to absorb biotechs with promising or approved drugs; the rare disease space notched approvals for therapies from Denali Therapeutics, Rocket Pharmaceuticals and Biogen; and Wave’s stock lost half its value after its RNA-based obesity candidate failed to impress investors.
The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.
While the accelerated approval unlocks only a small market opportunity for Rocket Pharmaceuticals, it will give the biotech a chance to prepare for future product launches, according to Jefferies.
Avlayah is the first Hunter syndrome therapy approved to address the condition’s neurologic complications, according to Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research.
At its peak, Imcivree’s sales in hypothalamic obesity could reach over $2 billion worldwide, according to analysts at Stifel.
With the approval of Wegovy HD, Novo Nordisk joins Johnson & Johnson, Boehringer Ingelheim and USAntibiotics as beneficiaries of the FDA’s Commissioner’s National Priority Voucher program, which aims to review products that align with certain national priorities in less than two months.
Protagonist Therapeutics will now sit back and collect cash from the J&J partnership, including an immediate $50 million payment.
Icotyde, co-developed by Johnson & Johnson and Protagonist Therapeutics, is backed by data from the Phase 3 ICONIC program, which, among other advantages, showed significant superiority over Bristol Myers Squibb’s Sotyktu.
The U.S. Senate has a plan to improve drug development for rare disease patients. The exit of controversial CBER chief Vinay Prasad will help clear the path.
PRESS RELEASES