Zyprexa Gains 1st Approvals In USA/EU For Schizophrenia

Eli Lilly has been granted approval in the USA and European Union for its new "atypical" antipsychotic agent Zyprexa (olanzapine). The drug is the first in a series of new antipsychotics, which it is hoped could improve the management of schizophrenics and improve their chances of reintegration into society.

Zyprexa was approved in the USA on October 1 "for the treatment of symptoms of psychotic disorders," while in the EU it was approved on September 27 "for the treatment of schizophrenia, the long-term maintenance treatment of schizophrenia and the treatment of comorbid depression, or depression that may occur with schizophrenia." The EU indication is notable in that it makes specific reference to depression, one of the negative symptoms of the disease which are poorly-addressed by almost all available drugs.

Olanzapine is set for a launch in the USA in "early October," according to Lilly. The company plans to launch the product in the UK on October 15, and a spokesman told the Marketletter that other European launches would take place as soon as possible, although clearly in some countries the firm still needs to negotiate pricing. In the USA, the net wholesale price for a 10mg tablet (the recommended daily dose) is $6.45, while in the UK it is L3.39 ($5.30).