Amvuttra, an Alnylam drug approved to treat nerve pain from transthyretin amyloidosis, is now FDA-approved for treating cardiomyopathy caused by this disease. The approval brings Amvuttra to a much bigger market, but it must compete with a blockbuster Pfizer drug already established as the standard of care.
Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.
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Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal.
As gene sequencing, machine learning, powerful imaging, sensors, gene and cell therapies make their way out of academic labs into everyday healthcare, our approach to healthcare is changing. For the first time, not only can we pinpoint the molecular and genetic causes of disease, but we also have the technologies to access them. On the back of this, prevention and cures are becoming possible. Can we afford them?
Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease. An FDA submission is planned, which would pit the Alnylam drug in competition with a blockbuster Pfizer product.
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
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Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech's fourth drug that works by RNA interference. Meanwhile the company is responding to a federal subpoena seeking documents related to the company's marketing and promotion of its first RNAi drug, Onpattro.
In an open letter published by BIO, the executives emphasized the importance of science-driven evaluation of medicines and regulatory independence. The letter came amid growing concern about political pressure over the FDA, as well as lack of diversity in trials and companies being too quick to announce data that are inconclusive.
The companies said Monday they had identified the first candidate for clinical trials, a direct-acting antiviral RNA-interference drug that they plan to develop as an inhaled therapy against the SARS-CoV-2 virus.
A key component of the deal includes a $1 billion purchase of 50% of royalties owed to Alnylam on sales of inclisiran, a drug for hypercholesterolemia that works by gene silencing. The company's CEO said uncertainty and volatility due to Covid-19 meant the timing was right for the deal.
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A panel at Biotech Showcase last week provided an outlook for a new class of drugs that only entered the market two years ago, but was decades in the making.
The deal was originally announced in November. The Medicines Co.'s lead product candidate is inclisiran, an RNAi drug for reducing cholesterol, for which it submitted an FDA approval application in December.
Executives from biopharma companies and an academic expert weigh in on what's in store for areas like cell and gene therapy, precision medicine and drug pricing.
Although it hasn't yet released details, the company announced positive data from two Phase III studies of inclisiran, which it is developing with Alnylam. The drug prevents production of PCSK9, the target of drugs made by Amgen and Sanofi/Regeneron.
Inclisiran, which The Medicines Co. is developing with Alnylam, prevents production of PCSK9, the same protein targeted by two drugs that were the subject of a major patent lawsuit ruling last week. The company plans regulatory filings starting later this year.