USFDA approves Remdesivir as first Covid-19 therapy amid WHO reservations

Approval unlikely to increase prices immediately as Gilead has said licenses are royalty-free until the end of the health emergency

Even as the World Health Organisation (WHO) trial showed that remdesivir did not have any significant impact on hospitalised Covid-19 patients, the US drug regulator has now approved this drug from Gilead for treatment of Covid-19 requiring hospitalisation. This becomes the first treatment of Covid-19 that got FDA approval, but is unlikely to have any immediate impact on the prices of the drug. 

The US Food and Drug Administration (UFDA) approved the antiviral drug Veklury (remdesivir) for use in adult and children of 12 years of age and older (weighing at least 40 kg) for treatment of Covid-19 that requires hospitalisation. It added that Veklury should be administered only in a hospital or healthcare setting that is capable of providing acute care comparable to inpatient hospital care. 

Veklury is the first treatment for Covid-19 to receive FDA approval. Earlier it had an emergency use authorisation (EUA) issued in May when the pandemic broke out. An EUA is basically an off-label therapy for any condition. 

 

Maintaining that the FDA is committed to expediting the development and availability of Covid19 treatments, Stephen M Hahn, FDA commissioner pointed out,“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from Covid-19 within 29 days of being treated. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe Covid-19 who received Veklury or placebo, plus standard of care.  This apart there were two randomised, open label, multi-center clinical trials on hospitalised patients. 

Will this raise remdesivir prices?

Apparently not yet. Gilead, the innovator of Veklury or remdesivir, has earlier indicated that the licenses are royalty free 'until the WHO declares the end of the Public Health Emergency of International Concern regarding Covid-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier.' It has signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to further expand supply of remdesivir. The agreements allow the companies like  Cipla, Dr. Reddy's Laboratories, Hetero Labs, Jubilant Lifesciences, Mylan; Syngene, a Biocon company  and Zydus Cadila Healthcare to manufacture remdesivir for distribution in 127 countries. 

 

The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.  

Prices of remdesivir are very competitive in India. In August Ahmedabad-based Zydus Cadila launched, what is perhaps the cheapest remdesivir brand in the world, Remdac, which it has priced at Rs 2,800 per dose. This is 30 per cent cheaper than its closest rival, Cipla’s Cipremi. 

Apart from remdesivir, Gilead has licensing agreements with 11 India-based generic pharma manufacturers to develop Hepatitis C compounds (sofosbuvir, ledipasvir, velpatasvir and voxilaprevir) for distribution in 105 developing countries.

According to these agreements, the generic licensees have the right to develop and market generic versions of Gilead’s HCV medicines. While the companies may set their own prices and receive a complete technology transfer of Gilead’s manufacturing process, they have to pay a royalty to Gilead.

Firms did not provide details of the royalty arrangements they have with Gilead. For HCV, Hetero, Zydus Cadila, Cipla etc have agreements with Gilead.