Lundbeck’s Serdolect deemed not suitable for broad use

Lundbeck’s Serdolect has been determined not to be suitable to treat a broad schizophrenia population due to safety concerns.

The Psychopharmacology Drug Advisory Committee, appointed by the Food and Drug Administration (FDA), came to this conclusion on a majority vote.

However, the common thought was there may be subpopulations where the therapy would be beneficial ? as long as there were appropriate labelling and risk management tools put in place.

Data supporting an additional regulatory claim related to helping suicidal behaviour in patients with schizophrenia was found to be insufficient by the committee.

Head of drug development and executive vice-president at Lundbeck Anders Gersel Pedersen said the company would work closely with the FDA as they move towards a decision on the new drug application.

“We are pleased with the advisory committee’s ? acknowledgement of ? [Serdolect’s] potential safe use in the right populations with appropriate risk management measures as it is important for patients to have multiple treatment options,” he remarked.

The company’s annual general meeting of shareholders will be held on April 21st.