European Medicines Agency - Withdrawals of Application - Medicinal Products for Human Use - Ellefore

RECOMMENDATION: desvenlafaxine
Based on the review of the data on quality, safety and efficacy, the CHMP considers that the application for Ellefore in the treatment of major depressive disorder is not approvable since "major objections" have been identified, which preclude a recommendation for marketing authorisation at the present time.

The major objections precluding a recommendation of marketing authorisation, pertain to the following principal deficiencies:

Efficacy and safety
The benefit-risk of desvenlafaxine is not positive. The overall efficacy documentation is not convincing.
Relative to the mother compound venlafaxine, desvenlafaxine appears less effective with a similar safety and tolerability profile. The clinical value of such a product is questioned:
• Evidence with respect to short-term efficacy is considered insufficient as only two of the fixed dose studies employed a dose range that is consistent with the proposed dose (studies 332 and 333) and as the results of these studies are mixed.
• Maintenance of effect was not demonstrated in the dose range that is proposed.
• The number of elderly included in the studies is not sufficient for demonstrating efficacy and safety in patients 65 years or older and is not sufficient for determining the adequate dose in this age group.

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European Medicines Agency - Withdrawals of Application - Medicinal Products for Human Use - Ellefore