EMA's CHMP Recommends Three New Medicines

Regulatory NewsRegulatory News | 20 September 2019 |  By 

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the approval of three new medicines, including one orphan product, and recommended extending the indication for eight other drugs.
The newly recommended medicines include Astellas' acute myeloid leukemia drug Xospata (gilteritinib), which was granted orphan designation and was reviewed under EMA's accelerated assessment program. The recommendation comes less than a year after the US Food and Drug Administration approved Xospata for the same indication.
The other two medicines are AstraZeneca's Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) to treat type 2 diabetes and Aerie Pharmaceuticals' Rhokiinsa (netarsudil) to treat glaucoma and ocular hypertension.
CHMP also recommended the authorization of three generic medicines, including arsenic trioxide, bortezomib and Ivozall (clofarabine).
Additionally, CHMP gave a positive opinion for Plethora Pharma Solutions' informed consent application for Senstend (lidocaine and prilocaine cutaneous spray) to treat premature ejaculation in adult men. Under an informed consent application, a sponsor references an authorized medicine with consent of the authorization holder, in this case the reference product is Plethora Solutions' own Fortacin.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy