Yahoo News Novartis seeks approval for COVID-19 drug
Novartis (NVS) has announced it is seeking approval from the Food and Drug Administration (FDA) for its antiviral COVID-19 treatment ensovibep (mp0420).
The Basel-based pharmaceutical firm added that it will in-licence the drug, which it has been developing with Molecular Partners, after positive trial data.
It will also exercise its option and pay 150 million Swiss francs (£120m, $163m) to accelerate manufacturing, and get approvals for the drug more quickly. Molecular Partners had already received an upfront payment of 60 million francs, including equity.
With the decision made to exercise the option, Novartis will become responsible for development, manufacturing, distribution and commercialisation activities of ensovibep.
It comes after its global clinical trials, which tested 407 patients during a Phase Two study, showed a 78% reduction in hospitalisations or emergency visits related to coronavirus versus a placebo.
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Ensovibep is a multi-specific DARPin (Designed Ankyrin Repeat Protein), specifically designed to block the receptor binding domains of SARS-CoV-2 spike protein through highly potent and cooperative binding, making it challenging for escape mutants.
The primary endpoint of the study showed a statistically significant reduction in viral load over eight days, it said. No deaths occurred in any of the patients treated with ensovibep, and all doses were well-tolerated with no unexpected safety issues identified for any of the doses.
The ensovibep treatment also maintains protection against variants identified so far, including Omicron.
If approved by the FDA, ensovibep will be the first multi-specific antiviral molecule for the treatment of coronavirus.
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“We are pleased that the results from the EMPATHY trial demonstrate the positive therapeutic effect of ensovibep, with the potential to be an important new treatment option to combat the rapidly evolving SARS-CoV-2 pandemic,” said Vas Narasimhan, boss of Novartis.
“As COVID-19 continues to burden healthcare systems across the globe, a range of treatments will be needed, and Novartis is proud to continue our collaboration with Molecular Partners on this unique treatment for COVID-19 and contribute ensovibep to this suite of options.”
Patrick Amstutz, chief executive of Molecular Partners, said: “These encouraging results come at a time when the need for therapies with pan-variant activity, such as ensovibep, has never been greater.
"We are incredibly excited about the opportunity to provide a potential therapeutic option for patients around the world who require access to effective COVID-19 treatments.”
