Monday, October 18, 2021

Appeals panel suggests approval of two experimental heart drugs

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In a bid to let more people benefit from an experimental drug designed to increase or preserve heart function, an advisory panel to the Food and Drug Administration voted that it should be allowed to be marketed as an add-on therapy for patients at high risk of cardiovascular disease. The committee of experts also voted that a similar drug, SIMS-20, for the treatment of graft versus host disease, should be approved.

The scientists recommended the approval of the drug in more specific applications to patients at high risk of contracting heart disease and those with a chronic condition, such as rheumatoid arthritis. Both therapies have “not shown a benefit in initial studies,” said Carl Elliott, director of the Center for Clinical and Translational Science, a division of the FDA’s Center for Drug Evaluation and Research, after the vote. But Mr. Elliott said he was optimistic about future clinical studies evaluating the drugs.

“We think we can do a lot more with both of them,” Mr. Elliott said.

With the decision, both drugs will advance further into human trials for the treatment of heart problems and the complications of graft versus host disease, a condition that affects the immune system and causes serious organ damage after stem cells are transplanted. Graft versus host disease is particularly difficult to treat because the transplanted cells contribute to the continuing damage. Experts say that patients with the condition tend to recover well if given radiation treatment and antiviral medication, but many do not, according to the American Heart Association.

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