MedWatch

Lundbeck's schizophrenia treatment for teenagers receives FDA priority review status

Lundbeck and partner Otsuka have completed a supplemental drug application for the FDA to expand the use of schizophrenia drug Rexulti, one year earlier than expected.

Photo: Thomas Borberg

In December, Lundbeck and its partner Otsuka could potentially see the indication of their treatmeant of schizophrenia, Rexulti, expanded to include an important patient group in the US.

The US Food and Drug Administration (FDA) has confirmed that the vetting work for the drug has begun, after the two companies asked to include patients as young as 13 years old in a supplemental application. Today, the drug is only approved for the treatment of adults with schizophrenia, in addition to its adjunctive therapy for in adults with major depressive disorder.

Read the whole article

Get 14 days free access.
No credit card required.

  • 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

"Real world" patient data documents the long-term effects of ALK vaccines

In the largest study ever of its kind, patient data from the "real world" documents the long-term effects of up to nine years of ALK vaccines. Up until now, it has not been possible to demonstrate these in ordinary clinical studies where the follow-up period is shorter, and the new knowledge could be a turning point in ALK's dialog about prices and subsidies with authorities and payers. 

Further reading

Related articles

Latest news

See all jobs