After Russia clears, India looks to expedite Favipiravir approval

India is working out ways to grant approval for Favipiravir as soon as concrete data comes in from Indian drugmakers that are running trials for the drug, said people in the know.

After Russia approved the use of Avifavir — a derivative of Favipiravir — for treatment of Covid-19, India wants to ensure the antiviral drug is available here soon.

At the moment, Mumbai-based Glenmark Pharmaceuticals is conducting a phase-3 clinical trial to test the efficacy of two antiviral drugs — Favipiravir and Umifenovir — as potential Covid-19 treatment strategy. These drugs have different mechanism of action and their combination can demonstrate improved treatment efficacy by effectively tackling high viral loads in patients in the early stages of the disease, the company said.

A source said almost 100 companies are ready to launch Favipiravir in the country once Glenmark presents its data.

Senior government officials indicated that any drug that is showing any promise for treatment of Covid-19 is put into a “rolling review”. “For Remdesivir, we got primary data from four global clinical trials and that is why the approval process was expedited. As for Favipiravir, Russia has approved it. But we do not have any data yet,” said a senior official. He added that once some concrete data arrives from the ongoing clinical trials, the drug approval process can be expedited. “Until there is a definite benefits exhibited by a drug, we cannot put patients at risk. Therefore, we are taking a judicious approach,” the official said.

In the absence of clinical trial data, the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) can review an application to consider approving a drug.

Glenmark is conducting phase-3 clinical trials on 150 patients. The patient recruitment is on for the trials. The drug is being used by some hospitals in Mumbai on compassionate use grounds. A source close to the development said the company might submit data from the trials conducted so far to the drug regulator soon. "It is in discussions with the CDSCO on a regular basis, updating about the trials. Data collected so far may be presented," said the source.

Glenmark did not wish to comment on how soon it expected to get the approvals.

The company said that the combination of Favipiravir and Umifenovir can result in greater clinical effectiveness. Both these drugs are oral and, thus, can be administered easily.

Government sources indicated that whether it is Remdesivir or Favipiravir, the drugs will be given under supervision of doctors in hospitals. "They can be made available at chemist shops, but selectively. Gradually, the oral drugs could be made available at chemists upon providing a valid prescription,” said the official.

On the pricing front, Favipiravir is expected to be cheaper than Remdesivir, which is an injectable. Pune-based Brinton Pharma, which is exporting the drug to 18 countries, has already seen a surge in demand for exports. Speaking to Business Standard, Rahul Kumar Darda, chairman and managing director of Brinton Pharma, said, "The drug is showing positive outcome in Covid-19, and is also less expensive compared to drugs like Tocilizumab. Moreover, it is in tablet form. So, demand for the drug is increasing from various countries.”

For countries like Nepal the drug is being priced around ~2,500 per strip of 10 tablets. A patient would need a course of 14-days, or roughly around 20 tablets or so, making the cost of therapy ~5,000. “When the drug gets launched in India eventually, the prices are expected to be lower,” Darda said.

Favipiravir has been in use for different types of influenza for years. It is also a generic drug. Since it has been used for influenza, researchers can now bypass the toxicity data, and the process of trial on Covid-19 patients can be faster.