India's drug controller declines Mylan's request

The Drug Controller General of India (DCGI) has refused to grant permission to Netherlands-headquartered generics company Mylan (Nasdaq: MYL) request to waive Phase III clinical trials for blockbuster hepatitis C drug sofosbuvir, in patients suffering with severe COVID-19.

Low-cost hepatitis C drugs sofosbuvir, marketed by Gilead Sciences (Nasdaq: GILD) as Sovaldi, used in combination with daclatasvir, has shown promise in reducing the chance of death among hospitalized Covid patients.

Mylan had asked for Phase III human clinical trials to be waived, arguing that studies in Iran have shown that sofosbuvir used in combination with another hepatitis C drug, daclatasvir, lowered fever and improved breathing in 94% of hospitalized patients, versus 70% in the case of those who did not get the drug combination but availed of the standard care.

The Iranian study, based on three trials, was presented at the International AIDS Society Covid-19 scientific conference in July.

The combination of drugs also reportedly reduced mortality, according to the studies, as the death rate in patients who had been administered the combination was 5%, versus 20% in the control arm.

However, in response to Mylan's request for waiver of clinical trials, a note by the subject expert committee at the Central Drugs Standard Control Organization (CDSCO) states: “The committee recommended that the firm should conduct a Phase III clinical trial on Indian patients and accordingly Phase III clinical trial protocol should be submitted for review by the committee.”

The CDSCO is the apex body to regulate clinical trials in India and is headed by DCGI.