The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
EMA announced on Nov. 16, 2018 that its human medicines committee (CHMP) recommended four drugs for approval. The approved drugs include the first oral-only tablet for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. The drug, Fexinidazole Winthrop (fexinidazole), has been approved for use outside the European Union under Article 58.
The other recommended drugs include a treatment for non-metastatic castration resistant prostate cancer, Erleada (apalutamide); a treatment for growth hormone deficiency in adults, Macimorelin Aeterna Zentaris (macimorelin); and the generic drug, Silodosin Recordati (silodosin), for the treatment of the signs and symptoms of benign prostatic hyperplasia.
CHMP also recommended extending the indications for Kisqali, Mabthera, Orkambi, and Ravicti. In addition, Blincyto’s (blinatumomab) indication was extended in patients with residual cancer cells after previous treatment. Positive opinions were adopted for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer).
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.