CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz

Regulatory NewsRegulatory News
| 15 October 2021 | By Michael Mezher 

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.
 
The recommendations include positive opinions for four medicines and one generic, as well as conditional authorization for Janssen's Rybrevant (amivantamab) for the treatment of non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations.
 
The recommendation for Rybrevant comes five months after the US Food and Drug Administration (FDA) approved the drug for the same indication following a review conducted under Project Orbis in concert with UK and Brazilian regulators.
 
The four new medicines include Gilead's triple-negative breast cancer drug Trodelvy (sacituzumab govitecan), Apellis Pharmaceuticals' Aspaveli (pegcetacoplan), which is marketed as Empaveli in the US, to treat adults with paroxysmal nocturnal hemoglobinuria, Pfizer's atopic dermatitis drug Cibinqo (abrocitinib) and Merck's 15-valent pneumococcal vaccine Vaxneuvance. The sole generic recommended for approval in this batch is Sun Pharmaceutical's sitagliptin to treat type 2 diabetes.
 
The committee also recommended extending the indication of 10 medicines, including AstraZeneca's Edistride (dapagliflozin) and Forxiga (dapagliflozin), Merck's Keytruda (pembrolizumab), Amgen's Repatha (evolocumab), AbbVie's Skyrizi (risankizumab), and Pfizer's Xeljanz (tofacitinib). Extended indications were also recommended for Eisai's Kisplyx (lenvatinib) and Lenvima (lenvatinib), CSL Behring's Hizentra (human normal immunoglobulin), and Bristol-Myers Squibb's Zeposia (ozanimod).
 
EMA also revealed that Incyte has withdrawn its marketing authorization application for Zynyz (retifanlimab) for the treatment of squamous carcinoma of the anal canal, after the agency raised major concerns about the application, which the company was unable to satisfactorily address.
 
Additionally, CHMP recommended against the authorization of Lidocain/Prilocain Idetec for preventing pain during minor surgical or other medical procedures and for treating leg ulcers following an Article 29 referral. The referral was prompted by a disagreement among EU member states over the benefit of the drug, which had been submitted as a hybrid application to the Danish Medicines Agency under the decentralized procedure. Following its review, EMA said the benefits of the drug do not outweigh its risks for the given use and that marketing authorization should not be granted in Denmark or the Netherlands.
 
EMA

 

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