Flurry of EMA/CHMP recommendations

At its January meeting, the European Medicines Agency’s Committee for Medicinal Products for Human USE (CHMP) recommended approval of eight novel medicines and one biosimilar. The final decision of the European Commission on the marketing authorization is expected in the coming months.

The Committee recommended granting a marketing authorization for Givlaari (givosiran), from Alnylam (Nasdaq: ALNY), the first treatment for acute hepatic porphyria in adults and adolescents aged 12 years and older. Acute hepatic porphyria is a rare life-threatening genetic condition that causes attacks of severe abdominal pain, vomiting and nervous system disorders, such as seizures, depression and anxiety.

Givlaari benefited from support of the PRIME scheme, the EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. This interaction led to a more robust application package to demonstrate the medicine’s benefits and risks, which allowed its accelerated assessment.