FDA considers ‘substantially inferior’ heart drug

Image copyright Merck Image caption The first clinical trials of a generic form of the heart attack-preventing drug – known as semagacestat – began in 1997 A panel of the US Food and Drug…

FDA considers 'substantially inferior' heart drug

Image copyright Merck Image caption The first clinical trials of a generic form of the heart attack-preventing drug – known as semagacestat – began in 1997

A panel of the US Food and Drug Administration (FDA) has been meeting to consider the safety and effectiveness of a generic version of Merck’s blockbuster heart attack-preventing drug.

Semagacestat had been on the market since 2002, but it lost patent protection in 2017.

The FDA’s advisory committee is now considering taking steps to approve the manufacturer’s oral version, Semagacestat Extended-Release (SEMS).

In a 25-2 vote, the panel sent a “positive” recommendation to the FDA.

Photo: Twitter

The FDA is not obliged to accept the advice of its advisory committees, but usually does.

Doctors and manufacturers of drugs can submit applications to the FDA for approval of generic products after a patent expires.

The decision is the latest news of the FDA’s continued embrace of generics, after it in the last decade approved nearly 2,000 such medications, including 34 new generics during 2018.

But the FDA recently came under criticism from President Donald Trump for not approving enough generics and the shortage of the common anti-convulsant drug indigestion medication, paroxetine.

SEMs are still the same drug as its original, but their use has been questioned since they are less effective.

FDA staff documents obtained by Reuters news agency reveal that studies of a generic version found the number of heart attacks was 30% less.

Photo: Getty Images

The semagacestat extended-release version was approved by the FDA in December 2017 for use in acute coronary syndrome, which includes heart attacks and heart failure.

‘Approved; asked for trade names’

In November 2017, the FDA added the generic version to its Approved Products List, meaning the drug could be marketed for sale at that time.

However, when Dow, the generic manufacturer of the original semagacestat, applied for approval to market it under its own name, it was denied.

Company officials later suggested that only those are approved drug labels, but it has been unclear for more than a year whether this is true.

Photo: Supplied

Just in August, Dow requested that the FDA allow its product to be legally marketed under the tradename nterotaxis.

At the same time, the FDA approved nterotaxis without that trade name.

The committee has now begun considering whether nterotaxis is approved in its current form for cardiovascular disease, or in another version with a different trade name.

“This is a decision that the FDA asked us to review,” George Sawaya, the director of the Office of Pharmaceuticals at the FDA, told the BBC in an interview on Wednesday.

In a presentation at the meeting, FDA staff said nterotaxis has received “conditional approval for cardiovascular indication, which allows us to take that product forward and promote it as a generic.”

However, at least one committee member questioned the safety of the treatment and, as a result, its benefits.

Dr Gilbert Ross, a cardiologist and editor of the journal Cardiology, asked whether nterotaxis was similar to the original product, or the competing version.

The company is seeking to obtain approval for a generic version of angiotensin II receptor blocker (ARB) monotherapy, which is currently on the market, but the FDA staff’s presentation asked whether nterotaxis was similar to ARB monotherapy.

FDA staffers said nterotaxis differed from the original ARB, such that it would be more likely to cause blood clots in the legs, because the manufacturing protocol, insulin and potassium concentration of nterotaxis differs from the original.

“Many adverse events [SENEs] that are very detrimental to the patient are not adverse events on the nterotaxis product that we would consider serious,” Dr Ross told the BBC.

“At least four deaths have been reported in studies.

“I think that if they were fatalities in my case there would be a major (federal) investigation.”

Dr P.M. Rao, another committee member, questioned whether similar complications had been observed in clinical trials.

Merck submitted a response saying it believed the drug had “performed well” in its trials.

In a statement to the BBC, the company said: “We believe we have strong data and we’re hopeful that the FDA will continue to approve nterotaxis.”

Source: BBC

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