Alcon withdraws further drugs from EMEA approval

Alcon has withdrawn two more drugs from the European approval process, the European Medicines Agency (EMEA) has said.

Last Thursday the EMEA announced that Alcon had withdrawn an indication for Retanne, designed to treat wet age-related macular degeneration (AMD) ? a major cause of blindness among the elderly.

In a statement the firm said that requests from the EMEA had influenced its change of heart, after it was “informed? that it would have to provide additional clinical data from existing and/or new clinical trials to support approval”.

However, it said that it would continue to develop wet AMD treatments for use in Europe, the US and worldwide, and is re-evaluating its clinical strategy.

The decision came exactly a week after Alcon withdrew an application seeking a new indication for Optanol. It had filed for the drug to be used as a nasal-spray for the treatment of hay fever.

Originally authorised as an eye-drop treatment for allergic conjunctivitis, regulators had provisionally decided not to authorise the extended indication until impurities in Optanol nasal spray had been shown not to cause harm.

However, the firm claimed to have pulled the indication away from approval as the result of its “marketing strategy”.

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