GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection.
Just months after the controversial FDA approval of Alzheimer’s disease drug Aduhelm (aducanumab), partners on that medicine, Eisai Co. Ltd. and Biogen Inc., are advancing a BLA for another possible AD therapy, lecanemab. Formerly known as BAN-2401, the Bioarctic AB-originated antibody is designed to neutralize and eliminate soluble, toxic amyloid beta for the treatment of early AD. The rolling submission, in pursuit of an accelerated approval, was primarily based on data from a phase IIb trial in people with early AD and confirmed amyloid pathology.
Bluebird Bio Inc. has completed a rolling BLA filing of beta-thalassemia gene therapy beti-cel in the U.S., with analysts predicting that the Cambridge, Mass.-based biotech will have to shoot for a lower price tag after running into trouble with cost regulators in Europe.
Little more than six months after filing a BLA for the antibody-drug conjugate (ADC) tisotumab vedotin in recurrent or metastatic cervical cancer, Seagen Inc. and Genmab A/S have secured an accelerated approval for the medicine. The green light for the co-developed product marks Seagen's third approved ADC and Genmab's first marketed therapy, though another medicine based on its Duobody technology platform recently won approval, too. The new cervical cancer drug, to be marketed as Tivdak, was approved for the treatment of adults experiencing disease progression on or after chemotherapy.
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease.
About a year and a half after Enzyvant Inc.'s tissue-based therapy for children born without a thymus met with a complete response letter over chemistry, manufacturing and controls concerns, its BLA is once again on track for FDA review, the company told BioWorld. Following a resubmission intended to fully address the agency's concerns, the application has a new PDUFA date of Oct. 8.
Amicus Therapeutics Inc.’s results from the phase III trial called Propel with AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease (LOPD) met with split opinions, though Wall Street took a decidedly dim view and left shares (NASDAQ:FOLD) to close at $12.57, down $6.16, or 33%.
Triggering a wave of commentary over its import, Biogen Inc. on Jan. 29 said the FDA has extended to June 7 its review of a BLA for the experimental Alzheimer's disease therapy aducanumab after the company submitted additional analyses and clinical data, making for a major amendment to the application. The three-month delay, from an earlier assigned PDUFA date of March 7, followed a thumbs-down vote by agency advisors in November. It sparked both sunny optimism and a bit of pessimism about the program's prospects on Friday.
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