Alnylam Pharmaceuticals
NEWS
The Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in favor of Alnylam’s patisiran on whether its benefits outweigh its risks for patients with cardiomyopathy induced by transthyretin amyloidosis.
The agency’s briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.”
After a three-month delay, GSK expects an FDA verdict for its myelofibrosis candidate, while Alnylam gears up for an advisory committee meeting discussing patisiran in cardiomyopathy of ATTR amyloidosis.
The RNAi therapy, which the companies are co-developing and commercializing, reduced blood pressure in hypertensive patients with high cardiovascular risk by 15 mmHg over placebo.
With an upfront payment of $310 million in cash, Roche is partnering with Alnylam to develop the latter’s RNA interference candidate zilebesiran for hypertension patients with high cardiovascular risk.
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
Part B of the study, cleared to proceed in Canada, remains on hold in the U.S. due to findings from non-clinical chronic toxicology studies.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
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