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

Novartis said on January 10 that positive data from a clinical trial of the COVID-19 therapeutic drug ensovibep prompted the company to exercise an antiviral licensing option from development partner Molecular Partners and subsequently seek approval for emergency use from US regulators.

In a statement, Novartis confirmed its plans to pay about $163 million to Molecular Partners for an in-house licensing, ramp up manufacturing more quickly, and seek faster regulatory permits worldwide, starting with an Emergency Use Authorization (EUA) request from the United States. . Food and Drug Administration (FDA).

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

“As COVID-19 continues to burden healthcare systems around the world, a range of treatments will be required, and Novartis is proud to continue our collaboration with Molecular Partners on this unique treatment for COVID-19 and to contribute to this range of options,” Vas said. Narasimhan, CEO of Novartis.

Novartis said that a phase II clinical trial found that insofibab 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 clinical recovery.

A separate preliminary in vitro study, cited by Novartis, found that ensophipp had “high neutralizing activity” against all known CCP virus variants, including Omicron.

“These encouraging results come at a time when the need for therapies with a wide range of activity, such as insofibib, has never been greater. We are very excited about the opportunity to provide a potential treatment option for patients across the world,” said Patrick Amstutz, CEO of Molecular Partners. around the world who need access to effective COVID-19 treatments.”

Novartis said that, if approved, Insavipipe would be the first multi-sex antiviral to treat COVID-19.

Last month, the US Food and Drug Administration approved Pfizer and Merck’s antiviral pills for certain groups of patients.

Pfizer’s drug, called Paxlovid, is licensed for those 12 years of age or older after trial data showed it was nearly 90% effective in preventing hospitalizations and deaths in patients at risk of serious illness.

Merck’s antiviral pill, caled molnupiravir, is licensed for use in patients 18 or older, with concerns about the drug’s effect on bone cartilage and growth precluding its use in younger patients, according to the Food and Drug Administration.

by Tom Ozymec

Tom Ozimek has an extensive background in journalism, deposit insurance, marketing, communications and adult education. The best biblical advice he’s heard is from Roy Peter Clark: “Hit your target” and “Leave the best for last.”


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