Wednesday, October 20, 2021

FDA panel: No clear benefits for adult PAH patients on COVID-19 and COVID-20

Getty Images The pulmonary arterial hypertension (PAH) drugs COVID-19 and COVID-20 should be given to adults with and without the rare syndrome known as ITP, but those adults who are also at risk for angina should not use them, the Food and Drug Administration’s (FDA) advisory panel said. The drugs, which have already been approved for use in adults with PAH, were supposed to help control the swelling that causes PAH

when patients have blood platelets in their bloodstream that are abnormally high. If patients do not need them, there are very limited drug options, said advisory panelist Dr. Peter Kaplan, who is the head of clinical research for GlaxoSmithKline (GSK)’s unit Varenicline. Both drugs appeared to curb the swelling and control symptoms of PAH in a blinded trial, Kaplan said. But Kaplan warned that “there’s an

unacceptable chance” that an older person could develop angina while on COVID-19. Angina is a potentially life-threatening condition where chest pain or an elevated heart rate occurs after the body tries to relax or constrict its muscles in response to increased exertion. The Food and Drug Administration panel voted 13-1 that the drugs should be “off-label” for use in patients who have ipledness or blood platelet

activity levels more than 100 million of those for which COVID-19 and COVID-20 are used. The FDA staff endorsed off-label use of the drugs in older patients with moderate-to-severe PAH, saying “new non-pharmacologic therapies are needed for patients with this condition”. Co-developer Halozyme Therapeutics told Reuters that company research showed no risks for diabetes in patients taking the drugs. Co-developer

Novartis (NVS) told Reuters that no adverse events due to use of the drug had been reported to doctors. COVID-19 (long-acting exenatide) is manufactured by Halozyme Therapeutics, and COVID-20 (short-acting erythropoietin receptor modulator) is manufactured by Novartis. Drugs like these are based on an enzyme that helps maintain the blood’s ability to clot by increasing the number of red blood cells. Those activated

cells normally help with bleeding by breaking down smaller blood clots in the circulatory system. But they can increase the risk of angina. A 2018 FDA study found that about 20 percent of patients in the COVID-19-approved trial were able to lower their blood platelet activity levels sufficiently to avoid angina. Co-developer Novartis “hopes that these results will help guide patients and providers toward use of our

drug as part of the continuum of care,” said Novartis spokeswoman Susan Eisenberg in an email. BMO Capital Markets said the panel’s decision “would increase our sector wide comfort that efficacy of the drugs will be enough to warrant a commercial future”. The FDA generally follows the advice of its advisory panels, although it is not required to do so. The FDA set the meeting for 10 a.m. EDT on Tuesday in Washington.

PAH, the most common cause of upper extremity paresis, is characterized by a deep, squeezing of the chest that causes shortness of breath and may cause mental impairment or upper respiratory infections. The condition is difficult to diagnose, and incidence is unknown because many patients die before they are diagnosed. In addition to COVID-19 and COVID-20, Halozyme also has two late-stage studies underway testing the

company’s enzyme against a category of approved anti-angina drugs. Halozyme expects to complete enrollment of that trial later this year.

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