Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
One of the companies wanting to be part of the upcoming U.S. launch of Humira biosimilars is instead exploring options to raise additional capital so it can continue advancing its biosimilar pipeline in the near term. Alvotech Holdings SA, a pure-play biosimilars company based in Iceland, initially had hoped for FDA approval June 28 for AVT-02, developed as both an interchangeable and biosimilar to the high-concentration formulation (HCF) of Abbvie Inc.’s blockbuster autoimmune drug, Humira (adalimumab).
Despite imperfect data and the use of post hoc analyses to overcome a failed endpoint, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 June 28 that Ipsen SA’s ultra-rare bone disease drug, palovarotene, demonstrated efficacy in treating patients with fibrodysplasia ossificans progressiva (FOP).
Opko Health Inc. stands to receive a $90 million milestone payment from partner Pfizer Inc. on the U.S. FDA approval of once-weekly human growth hormone analogue Ngenla (somatrogon) for pediatric patients with growth hormone deficiency. Pfizer expects to make the drug available to patients starting in August 2023.
With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie.
After nearly 10 years in clinical development and just a few months after an EMA rejection, Ipsen SA will be making its case June 28 before a U.S. FDA advisory committee for its ultra-rare bone disease drug, palovarotene.
Adults with generalized myasthenia gravis (gMG) have yet another therapeutic option, this time from UCB SA, with the U.S. FDA’s approval of orphan drug Rystiggo (rozanolixizumab-noli), a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor.
The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir).
Intercept Pharmaceuticals Inc.’s second attempt to score an expanded U.S. FDA approval of its farnesoid X receptor agonist, obeticholic acid, in patients with non-alcoholic steatohepatitis (NASH) went the way of the first, with the agency issuing another complete response letter (CRL), prompting the company to drop all NASH-related investment and cut a third of its workforce.
Sarepta Therapeutics Inc. is set to introduce the first gene transfer therapy for ambulatory patients diagnosed with Duchenne muscular dystrophy (DMD), after the U.S. FDA granted accelerated approval to SRP-9001 (delandistrogene moxeparvovec). Branded Elevidys, the therapy marks Sarepta’s fourth approved treatment for DMD and the first to offer patients a one-time treatment option.
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