Novartis and Incyte set to roll Jakafi – JAK inhibitor into COVID-19 clinical trial
Drug manufacturers across the world are rolling already authorized medicines into late-stage clinical trials in an initiative to find a quick therapy for COVID-19. Now, 2 more drugs are entering into late-stage clinical trials, with Swiss drug manufacturers Novartis and Incyte are all set to evaluate their blockbuster JAK inhibitor.
The Swiss drug manufacturer said in a release that Novartis and Incyte will start a stage 3 clinical trial for Jakafi-marketed as Jakavi abroad, to evaluate it as a treatment for cytokine storm-an immune overreaction that causes respiratory complications in severe COVID-19 patients.
The partners stated, “The proposed blind and double-arm study will assess a combination of Jakafi along with standard-of-care treatment to deal with COVID-19 patients having pneumonia”.
Novartis said, Jakafi’s potential star turn follows to “pre-clinical evidence and preliminary reports from independent researches” revealing feasible efficacy for COVID-19, and “considerable information on Jakafi’s safety and efficacy” treating with FDA-approved indications in acute graft-versus-host disease and myeloproliferative neoplasms.
John Tsai, Chief medical officer and head of global drug development, Novartis said, “The ability of Jakavi, that it could bring about faster recovery times for COVID-19 people with fewer calling for extensive treatment as well as mechanical ventilation is encouraging and absolutely qualifies for further investigation,” and “We now are rapidly moving to finalize the research study strategy and then to register eligible patients, in addition, to start a procedure to provide access for the trial for those who are incapable to participate.”
Both the companies – Novartis and Incyte are instantly presenting a compassionate use program for Jakafi pending local guidelines as well as “are taking steps” to handle an anticipated rise in demand that might impact patients who are currently taking the prescribed medication.
In 2011, the FDA initially approved Jakafi to treat myelofibrosis and additionally it is used to treat chronic graft-versus-host disease as well as polycythemia vera. In 2019 sales, the drug raked to $1.1 billion.
Novartis and Incyte’s campaign is just pharma’s newest push to repurpose drugs that are already approved to treat COVID-19 infection.
After President Donald Trump’s explicit support, Fujifilm’s flu antiviral Avigan may quickly get the FDA’s endorsement for emergency use.
Politico reported, citing three officials familiar with the discussions and internal documents that the Trump management asked the FDA to accredit Avigan’s emergency usage. Trump has previously talked about other medicines as potential against the COVID-19, including malaria medications chloroquine and hydroxychloroquine, which the FDA cleared for emergency situation usage without strong clinical proof of its impact on the coronavirus.
Avigan just won its initial approval for flu during the early days of the pandemic in China, the drug was labeled as “clearly effective” in treating COVID-19 by an official at the country’s Ministry of Scientific and technology, adding that the company has actually advised it to health authorities to consider in its therapy standards.
Drug manufacturers have so far floated a variety of possibilities with mixed clinical outcomes among with the pharma’s ever-expanding listing of feasible COVID-19 therapies.
Together with HIV-fighters and other antivirals, medicines from the IL-6 inhibitor class consisting of Sanofi and Regeneron’s Kevzara and Roche’s Actemra have aroused interest in scientists and motivated late-stage trials of their own.
Sanofi and Regeneron stated they had dosed the initial patient in their ex-U.S. arm of a worldwide phase 2/3 clinical program assessing Kevzara as a therapy for severe COVID-19. Regeneron said they will enlist around 300 individuals and study intravenous Kevzara as an add-on to supportive care through an “adaptive style“.
2 weeks back, Sanofi, as well as Regeneron, heralded the U.S. arm of the program, claiming the test would check Kevzara as an add-on to supportive care in 16 states for around 400 individuals.
Author: Sruthi S