Long-acting Zyprexa gets green light
pharmafile | October 2, 2008 | News story | Sales and Marketing | lilly, psych
Lilly's Zypadhera has been recommended in Europe for use in stabilising schizophrenic patients who are already receiving treatment.
The European regulator's key committee the CHMP has recommended the brand, a long-acting version of Lilly's blockbuster antipsychotic Zyprexa (olanzapine).
Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection) would be used in adults who are already stabilised during acute treatment with oral olanzapine.
The injection may improve treatment for those who struggle with sticking to oral regimes, the company said.
The investigational drug combines olanzapine with pamoic acid resulting in a salt that sustains the delivery of the original compound for up to four weeks.
The CHMP opinion is based on eight studies involving more than 2,000 patients, including a double-blind, placebo-controlled, fixed-dose study and six open-label studies.
The long-acting injection was found to be similar to the oral treatment in terms of rate of symptom exacerbation and showed a similar safety profile.
The new indication could represent a crucial revenue stream for Lilly since Zyprexa's patent only runs to 2011 in the US.
Generic companies including Israel's Teva have already mounted court challenges.
To put pressure on Lilly in the run-up to expiry, generic versions of Zyprexa and a rival fortnightly injection, Risperdal, are now becoming available in some European markets.
David McDonnell, clinical research physician at Lilly, said: "Because of the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of depot formulations available, we believe that olanzapine long-acting injection has the potential to become a valuable treatment option for patients."
Other rivals in the antipsychotic market include Janssen-Cilag's once-daily tablet Invega.
AstraZeneca has also just launched a once-daily version of its own schizophrenia treatment Seroquel in the UK – Seroquel XL (quetiapine prolonged release).
The drug is an improvement on the current twice-a-day dosing and allows patients to reach the target dose after just two days.
The CHMP's recommendation on Zypadhera still needs approval from the European Commission and a decision is expected before the end of the year.
Zypadhera has just been approved for use in New Zealand and reviews are ongoing in countries including the US, Canada and Australia.
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