Zydus Cadila Seeks DCGI Approval for Hepatitis Drug to Treat COVID-19

Zydus Cadila Seeks DCGI Approval for Hepatitis Drug to Treat COVID-19

The Pegylated Interferon Alpha 2b drug is supposed to be a single dose regimen that is less cumbersome and more affordable.

Patients who received pegylated interferon alpha 2b during the trial also showed a lower need for supplemental oxygen, clearly indicating that they were able to control respiratory distress and insufficiency, which has been one of the main challenges in the treatment of COVID- 19.

Pharmaceutical firm Zydus Cadila said on Monday that it has applied for the approval of the national drug regulator Drugs Controller General of India (DCGI) for the additional indication of its anti-hepatitis drug Pegylated Interferon Alpha-2b for the treatment. COVID-19 . Phase III clinical trials with pegylated interferon alpha 2b, which the company sells under the brand name ‘PegiHep’, have shown promising treatment results. COVID-19 Zydus Cadila said in a statement. Interim results indicate that the drug, when given at an early stage, could help patients recover faster and avoid many of the complications seen in the advanced stages of the disease, he added.

‘The treatment regimen would be less cumbersome and more affordable for patients, as pegylated interferon alpha 2b is a single dose regimen. It would also ensure better compliance, ‘said Zydus Cadila.

PegIFN has a very well-established multi-dose safety in patients with chronic hepatitis B and C for many years, he added.

Patients who received pegylated interferon alpha 2b during the trial also showed a lower need for supplemental oxygen, clearly indicating that they were able to control respiratory distress and insufficiency, which has been one of the main challenges in treatment. COVID-19 the statement said.

“With these positive results, the company has applied for approval for additional indication with DCGI for the use of PegIFN in the treatment of COVID 19,” he added.

The phase III trials were conducted in 250 patients at 20-25 centers in India and the detailed results of this will be published in a peer-reviewed scientific journal, the company said.

“We are encouraged by the results of the phase III study of pegylated interferon alpha 2b, which has confirmed the potential to reduce virus titers when given earlier in the disease,” said Cadila Healthcare physician Sharvil Patel.

With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapies, this marks an important milestone, he added.

In addition to conducting a phase II trial in Mexico, the company is also working with the United States Food and Drug Administration (USFDA) for pegylated interferon alfa-2b to initiate appropriate clinical trials in the United States. the company said.

Shares of Cadila Healthcare, the Zydus Group’s publicly traded entity, were trading at Rs 438.55 per scrip on BSE, down 0.75 percent from their previous close.

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