MedWatch

Orphazyme plans to resubmit FDA application in H2

After drug candidate arimoclomol, a treatment of metabolic disease Niemann-Pick C, was rejected by the US Food and Drug Administration last year, Orphazyme now aims to file another application at the agency in the second half of the year.

Photo: Orphazyme/PR

On Friday morning, windswept biotech firm Orphazyme has announced its intention to resubmit an application to the US Food and Drug Administration (FDA) for arimoclomol, a potential treatment of the metabolic disease known as Niemann-Pick type C (NPC).

Orphazyme’s lead candidate was rejected by the FDA in a so-called ”complete response letter” in June of last year.

Already a subscriber? Log in.

Read the whole article

Get access for 14 days for free.
No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
An error has occured. Please try again later.

Get full access for you and your coworkers.

Start a free company trial today

More from MedWatch

Further reading

Related articles

Latest news

See all jobs