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… which may include clinical trials as required under Indian regulations,” said Dr Subhash Mandal, national general secretary, Indian Pharmaceutical Association.
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The approval is significant because many high-risk patients continue to have elevated low-density lipoprotein (LDL) cholesterol despite treatment with standard oral medicines.Clinical trials involving 3,207 adults found the once-daily oral drug reduced LDL cholesterol by 56-59% over 24 weeks in patients already on maximally tolerated statins, delivering reductions comparable to injectable PCSK9 inhibitors and offering another option for those whose cholesterol remains uncontrolled despite existing therapy.However, cardiologists said that the drug is unlikely to become a first-line treatment.“The new oral therapy lowers LDL… by about 50-60%, making it a promising option for patients who prefer to avoid injections,” said Dr Ambuj Roy, Professor of Cardiology at AIIMS Delhi.