Alnylam Pharmaceuticals
NEWS
The FDA has accepted Alnylam’s supplemental New Drug Application for Amvuttra on the heels of BridgeBio’s Attruby nod, potentially giving Pfizer’s tafamidis franchise another competitor.
BridgeBio secured approval for Attruby Friday, along with the all-important mortality benefit that could give the drug a significant boost in the market against Pfizer’s tafamidis and potentially Alnylam’s Amvuttra.
Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
The entry of new players and new approaches into the ATTR-CM space could help bring down the cost of treatment, experts say.
Preliminary data from a late-stage trial of Alnylam’s RNAi therapy for ATTR amyloidosis with cardiomyopathy appear strong but details expected later this summer are critical.
A mid-stage study of Alnylam Therapeutics’ experimental RNAi-based drug to treat hypertension met its primary endpoint.
Alnylam Pharmaceuticals is modifying the primary and secondary endpoints of the Helios-B Phase III trial investigating its next-generation RNA interference therapy in patients with ATTR amyloidosis with cardiomyopathy.
Following the regulator’s denial of patisiran’s label expansion, Alnylam has published late-stage data for the RNAi therapeutic in The New England Journal of Medicine demonstrating its efficacy in ATTR-cardiomyopathy.
The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal.
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