The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s May 2023 meeting.
Ztalmy (ganaxolone) received a positive opinion for epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder. This genetic condition is defined by seizures starting during infancy.
The committee recommended granting a marketing authorisation for Pylclari (piflufolastat (18F)), intended for the diagnosis of prostate cancer. This medicinal product has potential to diagnose this cancer in high risk patients in early stages and for patients with suspected recurrence.
Therapeutic indication extension recommendations
The CHMP recommended two extensions of indication for medicines already authorised in the EU: Bristol-Myers Squibb’s Opdivo (nivolumab) and Sogroya (somapacitan) from Novo Nordisk A/S. Both medicines are currently pending a European Commission (EC) decision.
Re-examinations and withdrawals of medicines in the CHMP meeting
Following a re-examination, the European Medicines Agency (European Medicines Agency (EMA)’s human medicines committee confirmed its original recommendation to refuse granting a marketing authorisation for Sohonos (palovarotene). The treatment is intended for the rare genetic disease fibrodysplasia ossificans progressive. The condition causes extra bone to form in places outside the skeleton, such as in joints, muscles, tendons and ligaments.
Marketing authorisation applications were withdrawn for Asimtufii, intended as a maintenance treatment of schizophrenia, and Susvimo, for the treatment of neovascular age-related macular degeneration (AMD) in adults.
EMA validates first regulatory submission for CRISPR-based medicine
Following a review, the committee recommended that Adakveo (crizanlizumab) should no longer be used to prevent painful crises in patients aged 16 years and older with sickle cell disease. This is a genetic condition where a patients red blood cells become rigid and change from being disc-shaped to being crescent-shaped (like a sickle).
It was concluded that the benefits of Adakveo did not outweigh its risks. This outcome was based on trial results, which compared the effectiveness and safety of Adakveo with placebo in patients who had previously had painful crises leading to a healthcare visit. The study demonstrated that Adakveo did not lead to a decrease when compared placebo.
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