Pharma news – 4 June,2020

Remdesivir receives approval from the Indian government

Gilead Sciences antiviral drug, Remdesivir has grabbed the attention of many countries for its ability to treat Covid-19. It was granted the emergency use authorization by the USFDA^[1] in April,2020. The Japanese health regulators have also approved the use of Remdesivir in Covid-19 patients.

On 1 June,2020 this drug was approved by the Indian government. However, as per the DCGI^[2] , Remdesivir can only be used for treating emergency cases. Only five doses can be administered to these Covid-19 patients.

This condition is based on the evidence provided by Gilead Science Inc. The company claimed on 1 June,2020 that Remdesivir was effective only when given to moderate Covid-19 patients for 5 days. It further added that giving the patients Remdesivir for 10 days did not show any promising results. 

The reason for the effectiveness of the short-term course unlike the long-term course remains a mystery. It is currently being investigated by leading researchers globally.

In India, Cipla, Jubilant Life Sciences, Mylan and Hetero Drugs have been licensed to produce Remdesivir by Gilead till an alternative drug is discovered.

As of 2 June,2020 the number of positive Covid-19 cases in India surged to around 2 lakh. While around 97,581 patients were under treatment, about 95,527 patients has recovered. Maharashtra is the worst-affected state having around 70,013 Covid-19 cases and 2,362 deaths.

Abbreviation: 1. United States Food and Drug Administration

• Drugs Controller General of India

Gilead has allowed the Indian licensees to determine the market price of Remdesivir:

Gilead had received the approval of the Indian drug controller to sell its antiviral drug, Remdesivir in the country. It is permitted to sell this drug only for emergency cases. Gilead has also announced that its licensed manufacturers in India are free to set their prices. It further stated that its own brand of Remdesivir will be available in the Indian market from July,2020.

Remdesivie will be sold under the name of “Veklury” in India. At present, four companies, namely Cipla, Mylan, Jubilant Life Sciences and Hetero Drugs have been issued the manufacturing license from Gilead. But these drug firms are yet to receive the approval from the Indian drug’s controller for manufacturing.

A source from Mumbai has claimed that Hetero Drugs has decided to quote Rs.7000 for a 100mg vial of the generic version of Remdesivir. If the generic version is to be sold at this price, then the 5 day treatment regimen would cost around Rs.35,000 to Rs.40,000.  However, the company has refused to comment on this matter.

Gilead’s brand Veklury costs around $4,460 (around  Rs.3.34 lakh) for the entire treatment regimen in the United States. Analysts have also revealed that Remdesivir will be sold at $4,000 per course in Europe and $2,000 in the other markets. It is also speculated that the global sales of Remdesivir will be around $1.9 billion by the end of 2020.

The Indian government has not yet decided on the price of this drug. However, the National Pharmaceutical Pricing Authority (NPPA) can fix the price of this drug by invoking paragraph 19. Government officials have claimed that this will be done if deemed necessary. Paragraph 19 has already been invoked in the past to reduce the pricing of stents and knee implants. Currently, hydroxychloroquine is made available at less than Re. 1 to all the physicians involved in Covid-19 treatment.

Gilead has begun to increase its production supply and believes that a regular supply chain can be established from July,2020. It also expects a surge in the supply of Remdesivir in the coming year.

References:

^[1] – Remdesivir treatment doe COVID Live mint – 2 June,2020

^[2] – News from Gilead Pharma– The Economic times – 4 June,2020