Green light for two new medicines in the EU

The European Medicines Agency (EMA) has approved two new medicines at its May meeting. This brings to 30, the number of products given the green light by the EMA’s human medicine committee (CHMP) in 2023.

The new products are:

• Pylclari (piflufolastat (18F)), intended for the diagnosis of prostate cancer.
• Ztalmy (ganaxolone) for the treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder, a genetic disorder defined by seizures beginning in infancy.

The committee also recommended two extensions of indication for medicines that are already authorised in the EU: Opdivo and Sogroya.

Following a re-examination, the CHMP confirmed its original recommendation to refuse the granting of a marketing authorisation for Sohonos (palovarotene). This medicine was intended to treat fibrodysplasia ossificans progressiva, a rare genetic disease that causes extra bone to form in places outside the skeleton, such as in joints, muscles, tendons and ligaments, leading to progressively decreasing mobility and other severe impairments.