PRIME: EMA Says Yes To Only Three Of Twenty Hopefuls
The past few months have seen the European Medicines Agency award its much sought-after priority medicines designation to treatments for Hunter syndrome, bubble boy disease and narcolepsy.
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The company stopped Phase II clinical trials for TAK-994 to assess a safety signal and determine next steps for the drug, which is viewed as a key product in Takeda’s push for blockbuster revenue growth.
A new batch of marketing authorizations in Japan includes new therapies for high-need cancer indications and rare diseases, and the first nod worldwide for a novel lysosomal disorder treatment that can address serious CNS symptoms.
Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.