Explainer: Covid-19 treatment options available in the GCC

With your drug remdesivir receiving FDA approval for Covid-19 treatment, what is the process for getting approval for its usage in the GCC?
The US Food and Drug Administration approval for remdesivir was granted on October 22, 2020. In the GCC, we initiated discussions with national regulatory authorities in May 2020 to identify the most
appropriate regulatory pathways for the registration of remdesivir.

The current authorisations are at the federal level in each of the GCC countries, with approval already received in the UAE and emergency use authorisation in place in other GCC countries including Saudi Arabia, where the process for a full marketing authorisation approval by the Saudi Food and Drug Authority is in its final step.

While Covid-19 vaccines are receiving heightened attention, are there also several treatment options undergoing trials worldwide?
There are a number of treatments under investigation for Covid-19, but only one antiviral treatment is currently FDA-approved and that is remdesivir. The investigational treatments being explored include antiviral medications which work by interfering with the creation of new viruses, resulting in slowing or stopping the coronavirus from multiplying in cells. The others are immune enhancers with antibodies, either from convalescent plasma, which is filtered plasma from the blood of recovered Covid-19 patients rich with antibodies, or the direct use of monoclonal antibodies to help the patient immune system.

Anti-inflammatory and immune-suppressant medications to manage the most severe symptoms of Covid-19 due to immune system overreaction are among the other options. Supportive treatments that help Covid-19 patients include anticoagulants, respiratory support devices, vitamins and minerals.

In the GCC region, what is the process like for pharma firms to roll out new medications?
The first step in rolling out a new medication is to secure a “marketing authorisation” from the respective national regulatory agency. Pharma companies must submit applications through a national submission procedure or through a GCC centralised procedure. Launch and supply to the market depend on securing the appropriate regulatory approvals.

The pandemic has pushed pharma companies to accelerate research and production at unprecedented rates. How have they coped?
The biopharmaceutical industry is working around the clock to research and develop new vaccines and treatments, while testing the feasibility of existing medicines to help those infected with the virus.
The investments by biopharmaceutical companies over the past many years within new technologies, research and treatments have prepared the industry to act swiftly to respond to the pandemic. The industry has deep scientific knowledge gained from decades of experience with similar viruses such as Ebola, Zika, MERS and SARS.

Since last January, Gilead has taken multiple steps in the research field to identify a potential antiviral treatment for Covid-19, initiating or supporting many clinical trials to assess remdesivir’s efficacy and safety. Additionally, Gilead took measures to ramp up remdesivir’s production with an upfront investment of over $1bn to rapidly build supply for potential global demand.

Along with Covid-19, you are also developing treatments for HIV and HCV – can you elaborate?
To support HIV patients, we are currently launching in the Middle East a treatment based on a single tablet regimen, already being considered among the preferred treatment options in the majority of reference
international treatment guidelines. Gilead is developing treatments based on long-acting inhibitors to support patients who have developed multi-drug resistant HIV-1 infection. This inhibitor is being developed as a component of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1. In May 2019, the FDA granted breakthrough therapy designation for the drug.

Looking ahead, how has the pandemic impacted the future of the pharma industry?
The biopharmaceutical industry is working closely with governments and insurers to make sure potential Covid-19 treatments and vaccines are affordable and accessible to patients. Over the past few months, Gilead has donated the entire existing supply of remdesivir, totaling 1.5 million vials globally, to the majority of the countries in the Middle East to facilitate rapid access to patients.

Additionally, newly introduced regulatory flexibilities are fast-tracking the development of treatments and vaccines for the virus, with companies expanding manufacturing capabilities and even sharing available capacity to ramp up production once successful medicines or vaccines are developed and approved. Governments should continue to institute and strengthen policies that incentivise the development of treatments and vaccines.