21 дек. 2023 г. · The US Food and Drug Administration (FDA) declined to approve Merck's (MRK.N) drug for chronic cough, the company said on Wednesday.

17 нояб. 2023 г. · Gefapixant under the brand name LYFNUA, has been approved in Japan, Switzerland, and the European Union for treatment of adults with refractory ...

23 мая 2024 г. · NICE has terminated its appraisal of gefapixant (Lyfnua; Merck Sharp & Dohme) for the treatment of refractory or unexplained chronic cough in adults.

Gefapixant (Lyfnua®; Merck & Co.) is a first-in-class, non-narcotic, selective P2X3 receptor antagonist being developed for the treatment of refractory ...

21 дек. 2023 г. · Despite approvals in Europe and Japan, the FDA rejected the oral drug, citing a lack of substantial evidence for treatment effectiveness.

15 нояб. 2023 г. · Staff assessment of the data submitted by Merck showed a small reduction in cough frequency and side effects such as loss of taste in patients ...

24 янв. 2022 г. · However, last week, the drug was approved in Japan under the brand name Lyfnua. The FDA initially accepted the NDA on March 1, 2021. The NDA ...

24 янв. 2022 г. · In Japan, LYFNUA is the planned trademark for gefapixant; the trademark for gefapixant in other countries has not been approved.

Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough. The recommended dose of gefapixant is one 45 mg tablet taken orally ...

24 янв. 2022 г. · The FDA rejected Merck's chronic cough treatment, potentially setting up more breathing room for competitor Bellus Health in a first-to-market battle.