US Health Secretary Kennedy looks to fast-tracking approvals for rare disease drugs

Reuters
06-06
US Health Secretary Kennedy looks to fast-tracking approvals for rare disease drugs

By Sneha S K and Sriparna Roy

June 5 (Reuters) - Health and Human Services Secretary Robert F. Kennedy Jr. said on Thursday that the U.S. drugs regulator would look for ways to fast-track approval for rare disease treatments and remove obstacles to their path to market.

Kennedy made the comments at a U.S. Food and Drug Administration meeting to discuss cell and gene therapies, where panelists called for faster regulatory processes as they warned that other countries may overtake the U.S. in drug development.

"We are going to continue to figure out new ways of accelerating approvals for drugs and treatments that treat rare diseases, and we're going to make this country the hub of biotechnology innovation," Kennedy said.

Other members included industry executives, researchers and FDA staffers, among them Vinay Prasad, the FDA's top vaccine and biologics official.

The appointment of Prasad as the head of the FDA's Center for Biologics Evaluation and Research had stoked fears that he could raise the bar for companies to get approval for new drugs, including what are known as accelerated approvals for new potential treatments of serious conditions.

Prasad vowed at the meeting to rapidly make therapies available at the first sign or promise of biomedical success or action.

Shares of therapy developers Sarepta SRPT.O, Dyne Therapeutics DYN.O and Lexeo Therapeutics LXEO.O were trading between 1% and 3% higher in afternoon trading. U.S.-listed shares of uniQure UQ1.F rose 8.19% to $16.18.

Panel members said that the slower regulatory process for rare disease treatments risks the United States' position as a leader in the biotechnology sector at a time when drug development in China is accelerating.

"The path to approval is seen as so arduous. If firms feel there is no credible way to get new products approved here, they will simply relocate trials overseas or abandon them," panel member Carl June from University of Pennsylvania.

"We cannot afford that exodus," said June.

(Reporting by Sneha S K and Sriparna Roy in Bengaluru; Editing by Alan Barona)

((Sneha.SK@thomsonreuters.com))

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10