Wyeth pulls European application for Ellefore
pharmafile | October 16, 2008 | News story | Sales and Marketing |Â Â EU, Pfizer, depressionÂ
The European future of Wyeth’s depression treatment Ellefore has been thrown into doubt after the pharma company withdrew its application for approval.
Wyeth said it remained committed to making Ellefore – a follow-up to its blockbuster antidepressant Efexor – available in Europe, but did not elaborate on how it would do this.
The company said the move was “part of its global regulatory strategy”, but Ellefore has already faced a number of clinical issues and earlier this year Wyeth withdrew a European licence application for the drug in a different indication.
This followed advice from the CHMP in March. The regulatory advisers said more clinical data was needed to support desvenlafaxine’s application for a licence to treat vasomotor symptoms (hot flashes) associated with menopause.
Commenting on the latest European application withdrawal, chief medical officer Gary Stiles said: “We are considering a number of options to support depressed patients and their families. There are millions of patients with depression, and clearly more treatments are necessary.”
Desvenlafaxine is an important part of Wyeth’s strategy for dealing with looming generic competition to its top-selling Efexor franchise, which in the form of Efexor and Efexor XR earned the company $3.8 billion in 2007.
Ellefore (desvenlafaxine) delivers the major active metabolite of Efexor (venlafaxine) in its active state, which Wyeth hopes will give the drug benefits over Efexor.
Unlike venlafaxine, desvenlafaxine is not metabolised through the CYP2D6 pathway, the route through which most existing antidepressants are metabolised. This means that when Ellefore is co-administered with other medications there is less chance of interactions.
The drug is currently marketed as Pristiq (desvenlafaxine) in the US, where it was approved in March to treat major depressive disorder.
The approval was subject to several post-marketing commitments, including conducting a number of additional studies. These included a new long-term study, a sexual dysfunction study, pediatric studies a study exploring lower doses and a non-clinical toxicity study.
But the FDA has so far refused to grant it a licence for vasomotor symptoms due to concerns about its potential to cause heart and liver problems.
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