FDA rejects Pfizer's weekly growth hormone

The US Food and Drug Administration has given the thumbs-down to Pfizer’s once-weekly growth hormone, somatrogon, following a three-month delay in fall of last year. The firm is prepared to enter a dialog with the agency to move forward.

Photo: Cathal Mcnaughton/Reuters/Ritzau Scanpix

US-based pharmaceutical firm Pfizer has suffered a significant blow on the hunt to have its once-weekly growth hormone, somatrogon, approved for the US market.

In a press release, Pfizer announces that it has received a so-called ”complete response letter” from the US Food and Drug Administration (FDA), entailing the agency’s rejection of the would-be treatment of growth hormone deficiency (GHD) for pediatric patients.

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

In a world of options, Genmab's CEO chose partnerships

In 2015, Genmab partnered with relatively unknown biotech firm Biontech. Reflecting on how far Genmab has come since, CEO Jan van de Winkel is still confident that partnerships, rather than acquisitions, are the way forward. If it had acquired Biontech at the time, the CEO speculates Genmab may have put a stop to other activities – including the Covid-19 vaccine efforts that went on to save millions of lives. This and fairness are worth remembering as biotech firms are increasingly strapped for cash, van de Winkel reflects.

Analyst predicts slow start for Leo Pharma's Adtralza in UK

The take-up of Leo Pharma’s atopic eczema drug Adtralza in the UK will be slow-going, according to analyst bureau Global Data, after the British institute NICE released draft guidance where it was not recommend it as a standard treatment in England and Wales.

Further reading

Related articles

Latest news

See all jobs