Gilead buys Sarepta's priority review voucher for $125M: 3 takeaways

Sarepta Therapeutics on Thursday sold its priority review voucher to Gilead Sciences for $125 million, reports Regulatory Focus.

Here are three things to know.

  1. The voucher will allow Gilead to accelerate the Food and Drug Administration's approval process for any new drug from 10 months to just six.

  2. Sarepta won the voucher through the agency's rare pediatric priority review voucher program after its Duchenne Muscular Dystrophy drug Exondys 51 earned FDA approval in September 2016, according to the report.

  3. The deal marks the third priority review voucher Gilead has purchased. Last summer, the drugmaker bought a voucher from PaxVax for about $200 million and another from Knight Therapeutics in 2014 for $125 million. Gilead used the latter voucher to earn FDA approval for its HIV drug Odefsey, according to the report.

More articles on supply chain:

New patient advocacy group joins fight against high drug costs
4 thoughts from Bayer CEO on drug prices, Trump's meeting with pharma and more
3 ways supply chains can use Big Data

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars