Schizophrenia Daily News Blog

Serdolect to be sold in Europe

In a press release (marketing document) from Lundbeck pharmaceuticals today, it was announced that Serdolect (a drug for schizophrenia that was pulled from the market in 1998) was recommended to be made available, as described below:

"The CHMP (Committee for Medicinal Products for Human Use, an EMEA committee) has recommended that the marketing restrictions for Serdolect(R) can be lifted and that Serdolect(R) can be marketed according to the SPC (Summary of Product Characteristics). Serdolect(R) is a drug for the treatment of schizophrenia, and the drug is expected to become available for normal prescription in Europe and is expected to be launched in the first countries in the 2nd half of 2005.

Since CHMP's temporary suspension of the marketing authoritisation for Serdolect(R) in 1998, Lundbeck has included an additional 5,000 patients in a study confirming that Serdolect(R) can be prescribed safely.

"We are very pleased that Serdolect(R) will again become available as a prescription alternative for the treatment of schizophrenia. Schizophrenia is a serious disease, and there is still a great need for offering patients improved therapies. Schizophrenic patients frequently switch drugs, either due to side-effects or lack of response, and we look forward to the fact that patients now will have access to Serdolect(R) which is different from all other antipsychotic drugs available", says Anders Gersel Pedersen, Senior Vice President, head of Lundbeck's Development, and he continues: "We are pleased that the authorities, following their thorough review of the clinical data, support our evaluation of Serdolect(R)."

Serdolect(R) was discovered by Lundbeck, and the company holds the global rights.

More information: Lundbeck