In a meeting on Thursday, drug review panel of FDA has announced that studies for heart safety would require for approval of obesity drug.
Regardless of whether an obesity drug pose heart risk, pharmaceutical companies would have to conduct trial to demonstrate effect of obesity drug on heart, said USA FDA advisory panel. Majority of the members voted in favor of this regulation.
Most of the obesity drugs have history of posing heart risk, according to Dr. Marvin Konstam - one of the member of advisory panel who voted in favor.
FDA is not bound to follow recommendations given by advisory panel, however, FDA does follow most of the time.
Several pharmaceutical giants have been bracing hard to acquire approval for first weight loss drug in a decade. Vivus and Arena are two companies ahead of other drug manufacturers. In past, FDA had sought clinical trial data on heart risk for the drug Contrave.
Demand for current weight loss drug (such as Xenical) is going to be high following this regulatory guidance as new weight loss drug would take several years to reach market.
Experts are eying on what companies would do next in order to pass the new obstacle; would they conduct entirely new trial on heart risk? or they would just submit analytical data of existing trial. Needless to say, conducting clinical trial is super expensive. Drug companies recover the trial cost from consumers by increasing drug cost. So, even if a company manages to acquire approval for obesity drug, price of the drug would be too high to purchase for obese patients.
This is the second time FDA asked for clinical trial on heart risk, first time it was for diabetes drugs of type two diabetes. Apart from proving efficacy of drug in treatment, manufacturers of obesity drug and diabetes drug have to prove that their drug do not pose risk of cardiovascular diseases.
Regardless of whether an obesity drug pose heart risk, pharmaceutical companies would have to conduct trial to demonstrate effect of obesity drug on heart, said USA FDA advisory panel. Majority of the members voted in favor of this regulation.
Most of the obesity drugs have history of posing heart risk, according to Dr. Marvin Konstam - one of the member of advisory panel who voted in favor.
FDA is not bound to follow recommendations given by advisory panel, however, FDA does follow most of the time.
Several pharmaceutical giants have been bracing hard to acquire approval for first weight loss drug in a decade. Vivus and Arena are two companies ahead of other drug manufacturers. In past, FDA had sought clinical trial data on heart risk for the drug Contrave.
Demand for current weight loss drug (such as Xenical) is going to be high following this regulatory guidance as new weight loss drug would take several years to reach market.
Experts are eying on what companies would do next in order to pass the new obstacle; would they conduct entirely new trial on heart risk? or they would just submit analytical data of existing trial. Needless to say, conducting clinical trial is super expensive. Drug companies recover the trial cost from consumers by increasing drug cost. So, even if a company manages to acquire approval for obesity drug, price of the drug would be too high to purchase for obese patients.
This is the second time FDA asked for clinical trial on heart risk, first time it was for diabetes drugs of type two diabetes. Apart from proving efficacy of drug in treatment, manufacturers of obesity drug and diabetes drug have to prove that their drug do not pose risk of cardiovascular diseases.
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