March 28 (Reuters) - PTC Therapeutics ( PTCT ) said on

Friday its inherited progressive muscle-wasting disorder drug

will no longer be available for sale in the EU as the European

Commission has decided not to renew its authorization following

a prolonged review.

The EC's decision backs the negative opinion on the drug

given by the EU regulator's Committee for Medicinal Products for

Human Use (CHMP) in 2023, which was then reaffirmed in January

last year.

The drug, Translarna, had received conditional approval

in the European Union in 2014 to treat children aged five years

and older who can walk and are afflicted with Duchenne muscular

dystrophy (DMD).

"We are of course disappointed that after this prolonged

period of review the European Commission has decided to adopt

the CHMP negative opinion on Translarna," said PTC CEO Matthew

Klein.

Translarna is designed to boost production of a protein

called dystrophin, the absence of which causes muscle weakening

in patients with DMD.