1. Scrip
  2. >>Business
  3. >>Strategy

Alnylam Drops Label-Expansion Effort For Onpattro After FDA Complete Response

 
• By Joseph Haas

Giving up on adding a cardiomyopathy indication to Onpattro’s label, Alnylam now will focus on adding that disease to Amvuttra’s label. Onpattro got a thumbs-up from an FDA advisory panel in September.

Change of plan
Alnylam has revised its plans in cardiomyopathy following an FDA rejection • Source: Shutterstock

Alnylam Pharmaceuticals Inc. got a reminder of the necessity of following US Food and Drug Administration guidance on 9 October when it received a complete response letter for its supplemental new drug application seeking to add an ATTR cardiomyopathy indication to Onpattro’s label.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Strategy

Genentech To Try Repertoire’s Immune Synapse Technology In Autoimmune Disease

 
• By Joseph Haas

Deal snapshot: The Flagship portfolio firm will use its Decode platform to seek novel targets for an unspecified autoimmune disease, with Genentech holding license rights.

Europe Pharma Heavyweights Call For Higher Drug Prices At Home

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By Joseph Haas

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

Enzene Sees Tariff Exemptions For India, Front-Ends US Capacity

 
• By Vibha Ravi

Enzene's CEO Himanshu Gadgil anticipates exemptions for Indian products from US tariffs expected to be imposed on pharmaceuticals. In an interview ahead of the US Vice Premier's India visit, he also talks about front-loading capacity at Enzene's US plant and a change in its biosimilars strategy

More from Business

In Brief: Synthetic Design Lab Debuts With $20m To Advance Cutting-Edge ADCs

 
• By Sushmita Panda

As ADCs continue to be a growth area globally, a new US-based venture with novel platform technology has emerged from stealth mode with $20m in funding.

In Brief: DIOSynVax And ACM Biolabs To Develop Bird Flu Vaccine

 
• By Sushmita Panda

The collaboration, supported by UK and Singapore government agencies, aims to develop an mRNA-based, needle-free universal bird flu vaccine suitable for use in a pandemic.

Europe Pharma Heavyweights Call For Higher Drug Prices At Home

 
• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.