By Colin Kellaher
PTC Therapeutics has suffered another setback in its bid to keep its Duchenne muscular dystrophy drug Translarna on the market in Europe.
PTC on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has once again recommended against renewal of the conditional marketing authorization for Translarna.
The Warren, N.J., biopharmaceutical company said the European Commission will now review the CHMP's negative opinion, with a decision expected in about 67 days, adding that the drug will remain authorized in Europe pending the review.
PTC initially won European conditional marketing authorization Translarna in 2014.
The CHMP in September 2023 gave a negative opinion on the conversion of the conditional marketing authorization to full approval, as well as a negative opinion on a renewal of the conditional green light. The panel had already maintained its negative opinion on the conditional renewal twice this year following re-examinations.
Translarna accounted for $70 million of PTC's second-quarter revenue of $187 million.
PTC has been working for years to win approval of Translarna from the U.S. Food and Drug Administration, which has turned the drug away three times. The company made another FDA submission in July.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 18, 2024 07:58 ET (11:58 GMT)
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