CHMP backs eight medicines for approval, recommends ranitidine suspension

Regulatory NewsRegulatory News | 01 May 2020 |  By 

At its meeting earlier this week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of eight medicines, including two versions of the first triple combination asthma inhaler and two new orphan medicines.
The committee also recommended the suspension of ranitidine medicines in the EU following a review of the drugs triggered by the detection of N-nitrosodimethylamine (NDMA) impurities. The recommendation follows the US Food and Drug Administration’s decision to request the withdrawal of the drugs from the US market. (RELATED: FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns, Regulatory Focus 1 April 2020; EMA, FDA begin reviewing heartburn medicines for carcinogen, Regulatory Focus 13 September 2020).
EMA says that Novartis’ triple combination therapy asthma inhaler Enerzair breezhaler (indacaterol/glycopyrronium/mometasone), and its duplicate Zimbus breezhaler, are the first to be recommended. The inhalers feature an optional digital sensor that can collect and transmit usage data to a patient’s smart device.
CHMP recommended two new orphan medicines at the meeting, Pfizer’s acute myeloid leukemia drug Daurismo (glasdegib) and Celgene’s Reblozyl (luspatercept), which is being recommended to treat adults with transfusion-dependent anemia associated with myelodysplastic syndromes or beta-thalassemia.
The committee also backed the authorization of Sanofi-Aventis’ biosimilar Insulin aspart and gave a positive assessment of Accord’s hybrid application for cabazitaxel and generic version of fingolimod, in addition to recommending Janssen-Cilag’s version of Xeplion (paliperidone), which was submitted via an informed consent application.
CHMP recommended extending the indications for nine medicines, Pierre Fabre Medicament’s Braftovi (encorafenib), Ablynx’s Cablivi (caplacizumab), Obvius Investment’s Carmustine Obvius (carmustine), Pfizer’s Ecalta (anidulafungin), Gilead’s Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir), Vertex’ Kalydeco (ivacaftor), Eli Lilly’s Taltz (ixekizumab) and Alexion’s Ultomiris (ravulizumab). New formulations of Janssen’s Darzalex (daratumumab) and Indivior’s Suboxone (buprenorphine/naloxone) were also recommended during the meeting.


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