CHMP recommends 6 drugs for authorization, Incyte withdraws application for Zynyz


Posted on October 15, 2021 | Through Michel mezher

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended marketing authorization for six new medicines in the EU.

The recommendations include positive opinions for four drugs and one generic, as well as conditional authorization for Rybrevant by Janssen (amivantamab) for the treatment of non-small cell lung cancer with exon 20 insertion mutations activating the epidermal growth factor receptor.

The recommendation for Rybrevant comes five months after the United States Food and Drug Administration (FDA) approved the drug for the same indication following a review conducted as part of Project Orbis in conjunction with UK regulators and Brazilian.

The four new drugs include Trodelvy (sacituzumab govitecan), Gilead’s triple negative breast cancer drug, Aspaveli (pegcetacoplan) by Apellis Pharmaceuticals, marketed as Empaveli in the United States, to treat adults. with paroxysmal nocturnal hemoglobinuria, atopic dermatitis from Pfizer (a Cibrocitibo drug) and the 15-valent pneumococcal vaccine from Merck Vaxneuvance. The only generic recommended for approval in this batch is Sun Pharmaceuticals sitagliptin for the treatment of type 2 diabetes.

The committee also recommended extending the indication of 10 medicines, including Edistride d’AstraZeneca (dapagliflozin) and Forxiga (dapagliflozin), Keytruda de Merck (pembrolizumab), Repatha d’Amgen (evolocumab), Skyrizi d’AbbVie (risankizumab) ) and Pfizer (Xelinjanz de Pfizertofa). Extended indications were also recommended for Eisai’s Kisplyx (lenvatinib) and Lenvima (lenvatinib), Hizentra from CSL Behring (human normal immunoglobulin) and Zeposia from Bristol-Myers Squibb (ozanimod).

The EMA also revealed that Incyte had withdrawn its application for marketing authorization for Zynyz (retifanlimab) for the treatment of squamous cell carcinoma of the anal canal, after the agency raised major concerns about the application, which the company has not been able to respond to satisfactorily.

In addition, the CHMP advised against the authorization of Lidocain / Prilocain Idetec for the prevention of pain during surgery or other minor medical procedures and for the treatment of leg ulcers following a referral under l Article 29. The referral was prompted by a disagreement between EU member states on the benefits of the medicine, which had been submitted as a hybrid application to the Danish Medicines Agency under the decentralized procedure. As a result of its review, the EMA stated that the benefits of the drug do not outweigh its risks for the given use and that the marketing authorization should not be granted in Denmark or the Countries -Low.


© 2021 Society of Regulatory Affairs Professionals.

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