Coronavirus Update: Generics And Hurdles For Molnupiravir, More Japan Approvals
Plus, Valneva Promise Vs Omicron, CalciMedica Drug Progresses
More generic deals but also US approval hurdles for Merck's oral antiviral, while Japan approves more options and Valneva's vaccine candidate shows promise against Omicron.
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Torrent expects US FDA’s final approval for Allergan/Almirall’s Aczone, a dapsone formulation for acne vulgaris, in February, even as it awaits regulatory clearance for manufacturing sites. Meanwhile, it has launched molnupiravir in India and is hiking its domestic sales force by 400-500.
Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA
Reviewers believed it was worth making the oral antiviral available for second-line use under the relatively low bar for emergency authorization despite the drug’s significant potential risks, ‘modest benefit’ and ‘unexplained difference’ in efficacy results from the interim and full analysis populations in the pivotal trial.
India authorizes molnupiravir for restricted emergency use in COVID-19, marking the arrival of around a dozen “affordable” generics of Merck & Co. and Ridgeback Biotherapeutics' oral antiviral. Physicians say data are “pretty compelling” notwithstanding the narrow FDA nod.