Swiss drug maker Roche Pharma said it is working with the Indian drug regulator to accelerate an emergency use authorization (EUA) for its investigational antibody cocktail Casirivimab and Imdevimab in India, based on the data that have been filed for the emergency use authorisation (EUA) in the US and the CHMP scientific opinion in the EU.
"An emergency use authorization in India would enable the import of globally manufactured product batches to India as soon as possible," Roche said.
Neutralizing antibody cocktails may play a role in the fight against COVID-19, in treatment of high-risk patients before their condition worsens.
Capacity expansion of Tocilizumab
The company on Wednesday said that it is also working urgently to increase manufacturing capacity and supply by ramping up our own production network, as well as actively collaborating with external partners to maximize production of Actemra (Tocilizumab) wherever possible with the goal of increasing its availability.
"We have observed an unprecedented demand for Tocilizumab (Brand: Actemra) given the significant increase in Covid cases across India in the last few weeks," Roche said in a statement.
"We are responding to this situation with supplies over this and the coming weeks to meet the immediate emergency demand. However, we are mindful that the current unprecedented demand may far exceed the supplies we can provide at this moment," Roche said.
Tocilizumab is considered for patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids.
The drug, which has to be taken in two doses, is manufactured by Roche and imported and distributed by its partner Cipla in India.
The drug went out of stock in the country a few weeks ago due to a sudden surge in its demand because of a sharp rise in COVID-19 cases in the country in this month.
