US FDA nod for 1st pill to replace jabs to fight high cholesterol
The US FDA has approved Lipfendra, the world's first oral PCSK9 inhibitor, providing a new treatment option for patients with high cholesterol who struggle with injectable medications. While the drug shows significant efficacy in clinical trials, experts note it is not expected to replace standard treatments immediately and will require separate regulatory approval for use in India.
Why it matters
This approval represents a major shift in cardiovascular care by offering a non-injectable alternative for high-risk patients, potentially improving treatment adherence and patient quality of life.
NEW DELHI: Patients with difficult-to-control high cholesterol could soon have an oral alternative to cholesterol-lowering injections after US Food and Drug Administration approved the world's first oral PCSK9 inhibitor, a class of medicines that dramatically lowers "bad" cholesterol.The tablet, Lipfendra, has been approved for adults with high cholesterol, including those with an inherited condition called heterozygous familial hypercholesterolaemia.However, the drug is not expected to be available in India immediately. "Even if a medicine is approved abroad, it cannot be marketed in India automatically... it must obtain approval from CDSCO...
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