Novartis Seeks Nod for Covid Drug in U.S. Before Final Test

(Bloomberg) -- Novartis AG will seek to bring its experimental Covid-19 drug to patients without waiting for results from a large clinical trial, Chief Executive Officer Vas Narasimhan said, potentially giving governments another option to battle the latest pandemic onslaught. 

The Swiss pharma giant aims to request an emergency-use authorization for the compound, ensovibep, with the U.S. Food and Drug Administration within the next month, Narasimhan said in an interview. A larger study to confirm promising data that emerged this week could be finished by the second half of the year, he said. 

“Our aspiration at the moment is to see if we get an emergency-use authorization and interest from certain governments to even utilize the medicine during these waves that are ongoing,” Narasimhan said.

Novartis is pushing forward with the medicine, which is given as an injection in a doctor’s office, as a wave of infections from the super-transmissible omicron variant crests around the world. Vaccines are less effective against omicron, though they’ve remained a strong shield against hospitalization and severe illness. 

The drugmaker’s shares fell 0.6% in Zurich, while shares of Molecular Partners AG, its partner on the potential Covid drug, climbed as much as 10%. 

Drug prescription trends so far suggest that omicron is having less impact on other areas of health care than previous Covid waves did, according to Narasimhan. Earlier swells had damped demand for some of the other types of medicines Novartis sells, including eye and skin therapies as well as generic drugs. 

It’s too early to predict whether omicron will move the world closer to a situation of endemic Covid, said the 45-year-old CEO, a doctor who led vaccine development at Novartis and worked on public-health issues including HIV, malaria and tuberculosis before his corporate career. 

“It’s obviously too soon to tell how much immune response omicron is generating, given that in many people it seems to be a mild illness,” he said. “Rather, what I would say is if you take it on a longer view, as we get through more and more of these waves and we get hopefully more and more people vaccinated and boosted, that you’re eventually getting to this equilibrium state.”

Novartis could produce millions of doses of its ensovibep drug this year, he said, though it remains to be seen how quickly the capacity can be brought to bear in the first half of the year. “We’re working very hard at the moment to see how fast we can scale up.” 

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