Novartis to Seek FDA Emergency Use Approval for New COVID-19 Therapy

Swiss drugmaker Novartis' logo is seen at the company's plant, in the northern Swiss town of Stein, Switzerland, on Oct. 23, 2017. Arnd Wiegmann/Reuters

Novartis said on Jan. 10 that positive data from a clinical trial of COVID-19 therapeutic drug ensovibep has prompted the firm to exercise an option to in-licence the antiviral from development partner Molecular Partners and later seek emergency use approval from U.S. regulators.

In a statement, Novartis confirmed plans to pay around $163 million to Molecular Partners to in-licence ensovibep, ramp up manufacturing more quickly, and seek faster regulatory authorizations across the globe, starting with an application for emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Ensovibep is designed to block the receptor binding domains of the spike protein of the CCP (Chinese Communist Party) virus, also known as SARS-CoV-2, which causes COVID-19. Novartis said the drug’s so-called multi-specific protein-based domains ensure strong neutralization of the CCP virus, even in the face of mutations of the pathogen’s spike protein, while limiting the development of escape mutants.

“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,” said Vas Narasimhan, CEO of Novartis.

Novartis said the Phase 2 clinical trial found ensovibep reduced viral load over eight days, while showing a 78 percent reduction in COVID-19-related hospitalizations or emergency room visits, and an improvement in time to a clinical recovery.

A separate preprint in vitro study, cited by Novartis, found that ensovibep has “high neutralization activity” against all known CCP virus variants, including Omicron.

“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,” said Patrick Amstutz, CEO of Molecular Partners.

Novartis said that, if approved, ensovibep will be the first multi-specific antiviral for the treatment COVID-19.

The FDA last month approved Pfizer’s and Merck’s COVID-19 antiviral pills for certain groups of patients.

Pfizer’s drug, called Paxlovid, was authorized for those aged 12 or older after trial data showed it to be nearly 90 percent effective in preventing hospitalizations and deaths in patients at high risk of severe illness.

Merck’s antiviral pill, caled molnupiravir, was authorized for use in patients 18 and older, with concerns about the drug possibly affecting bone cartilage and growth precluding its use in younger patients, according to the FDA.