Image copyright Merck Co. Image caption The pill (pictured) has been tested against standard cholesterol medicines
A key US panel has been told the Merck Co pill can help people put on weight, while maintaining their cholesterol levels.
In a public meeting in Washington, DC, the Federal Drug Administration panel said it would probably approve the medicine as long as a black box warning was added.
The black box warning is an alert when a medication has a serious side effect.
Merck applied for approval of the drug, which is known as grazopristone acetate, in June.
It is the company’s biggest experimental medicine but faces long odds of winning approval, and a 10% discount to normal prices in the US could do little to push up demand.
Call to use diuretics
The panel heard from the public, leading experts and Merck that grazopristone acetate could help people control cholesterol, a key risk factor for heart disease.
However, some audience members wanted it to include a label to warn it can cause weight gain.
America’s leading heart expert Dr Michael Thun, from George Washington University, told the panel that patients needed to be warned to use diuretics to suppress water retention during the first month of treatment.
One member of the audience asked if he would be interested in taking it, as he was overweight. He could not say no, as no one had ever told him it was safe to be overweight.
Poppy Silver, a dietitian with the American Heart Association, pointed out that there was little research to show it had any significant long-term benefit, unlike other cholesterol lowering treatments.
‘Nice’ side effect
At the same time, Merck’s Dr Tresa Tolley acknowledged that grazopristone acetate can result in weight gain after a month of taking it.
Merck said it would phase out this additional risk in later trials.
It said that the “important” protective effects it could provide when taken with statins showed that it would not significantly increase weight gain and should be acceptable.
The panel of experts will recommend whether the drug should be approved to the FDA.
The full result of the vote will not be released until Friday, but will likely also include any discussion around grazopristone acetate’s safety.
In July, Merck’s rival drug, a statin known as ezetimibe (Zetia), was expanded in the US to treat high levels of low-density lipoprotein (LDL) cholesterol.
‘Driver of resistant hypertension’
LDL cholesterol is the “driver of resistant hypertension”, or “dangerous high blood pressure”, and much of the trial results were on the efficacy of grazopristone acetate as an alternative to Zetia.
A large UK trial published in the Lancet journal in July found that patients taking the Merck drug could better maintain their cardiovascular health.
Professor Ian Sharp, of the University of Sydney, who helped conduct the trial, said the numbers seemed strong.
“It would appear that they are in a position where we can extend that group of people that have very high lipoprotein, and have a beneficial effect,” he said.
Merck, which makes Vytorin, was bought by Pfizer for $65bn (£44bn) in 2015.
In a regulatory filing, the company told investors it was hopeful that grazopristone acetate could be a novel treatment that combines long-term statin use with intensive lifestyle changes.