Glenmark Pharma gets US FDA nod for Ryaltris nasal spray

Ryaltris is a nasal spray. It’s a new drug application by Glenmark Pharma and it will be used to treat allergic rhinitis and other conditions.

The drug is going to be marketed and distributed via the US partner Hikma.

The delay in Ryaltris was because they had received a complete response letter (CRL) in June 2019 from the US drug regulator. So, the street was waiting and watching in terms of whether or not they would manage to solve the CRL query successfully and finally see the light of day.

This particular drug, Ryaltris, has been approved in Australia, Poland, Russia, South Africa, Ukraine, Czech Republic, and in April 2021 there was an enabling approval for 17 countries in Europe as well. They have entered into commercial agreements with multiple partners, for example, Hikma in the US, but in the European Union (EU) as well as in Canada where this drug is under review.

This is big news for Glenmark because this particular drug is a new drug application by Glenmark, which finally got the US nod and has been in the works for a while.

Watch the accompanying video of CNBC-TV18’s Ekta Batra for more details.