Roche seeking fast approval of antibody cocktail in India to treat Covid

Co says demand for tocilizumab may exceed supplies it can provide

Swiss giant Roche Pharma said on Wednesday that it is working with Indian authorities to accelerate the emergency-use authorisation (EUA) for its investigational antibody cocktail (Casirivimab and Imdevimab) in India. 

It is seeking an EUA in India based on the data filed for getting the EUA in the US and also scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the EU. Once it gets an EUA here, it can import the globally manufactured product batches to India as soon as possible, the company said. 

It added that it is also trying to expand production of tocilizumab (brand name Actemra) to meet demand in India amid rising cases. 

"We have observed an unprecedented demand for Tocilizumab (Brand: Actemra) given the significant increase in Covid cases across India in the last few weeks. 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," a company statement said. 

Roche said it is working urgently to increase manufacturing capacity and supply by ramping up our own production network, as well as actively collaborating with external partners to maximise production of Actemra wherever possible with the goal of increasing its availability. "This should enable us to meet future demand in a fluid and hard to predict environment. With the rising number of infections in India, minimising hospitalisation and easing pressure on healthcare systems is particularly important. This is where neutralising antibody cocktails may play a role in the fight against Covid-19, in treatment of high-risk patients before their condition worsens," it added.