May 26, 2022

UK Authorizes Anti-Viral Pill, First Seen to Treat CoVID

The UK has approved the use of an antiviral pill for treatment of COVID, a virus that can lead to complications such as blindness and respiratory problems. The drug is called ixekizumab, and it was developed by Merck. It will be used for patients aged 12 years or older who have not responded to other treatments.

About 100,000 people are estimated to suffer from COVID. It is more common among African-Americans than other ethnic groups, with about 2% of African-Americans suffering from this condition. The drug has proven its safety and efficacy in clinical trials involving over 1,800 patients. According to the European Medicines Agency (EMA), some patients have experienced relief from symptoms after just 4 weeks of treatment.

These additional approvals mark an important milestone in our commitment to help address the serious burden of psoriasis across Europe, said Michael Severino, MD, executive vice president of research and development at Merck Research Laboratories. We are dedicated to developing innovative therapies that can improve the lives of people with serious autoimmune diseases.

The approval was based on results from the LIBERATE clinical trial , which showed that taking ixekizumab lead to significant improvement in symptoms versus placebo. The drug works by stopping the action of certain immune factors called IL-17 cytokines, reducing inflammation and thereby lessening itching, scaling, redness, and thickness of skin.

The decision to approve follows several months after the European Commission validated an orphan designation for ixekizumab for this use , which is especially significant because it allows the drug to be marketed without any kind of patent protection. Orphan drugs are those that treat rare conditions (less than five people in 10,000). Because of this designation, Merck is entitled to 10 years of market exclusivity across all European Union countries.

Ixekizumab was approved by the FDA in March 2017 for US patients suffering from moderate-to-severe plaque psoriasis. On May 11th , ixekizumab got another green light from the FDA for psoriasis treatment.

Twenty-five percent of European patients with moderate plaque psoriasis do not respond to first-line therapies, according to Merck Research Laboratories . This statistic is called Psoriatic Disease Market Forecasts and it was compiled by Decision Resources Group in 2016. Moreover, some available treatments can lead to serious side effects and can be expensive. According to this report, costs for psoriasis treatments were estimated at $3.2 billion in 2016 and they are expected to increase by 8% per year over the next three years (2017-2019).

The approval of ixekizumab is welcomed as an improvement in treatment options given the number of people that suffer from this condition. It is already known that genetic differences can influence disease development and course, and now we know that how an individual’s genes respond to a specific drug treatment could also be important for achieving clinical benefit.

This was shown in a study published last year by researchers from the University of Illinois , where they identified a genetic marker that is associated with the response to treatment using Tofacitinib or Another IL-17 Inhibitor for psoriasis . According to this study, people who carry a certain variation of a gene called CTLA4 are more likely to respond to one of these drugs.

Everyone’s genetics are unique and special features in our DNA are associated with different traits, including risk factors for disease development. As part of their work , researchers sequence our DNA –that is, they look at all 3 billion nucleotides that make up the human genome– to identify certain changes in the genetic code that may cause or increase the risk of developing a certain condition.