US FDA nod for 1st pill to replace jabs to fight high cholesterol - The Times of India

What the report says

The Times of India reported that the US Food and Drug Administration has approved Lipfendra, described as the world’s first oral PCSK9 inhibitor, for adults with high cholesterol. The medicine is intended for patients whose cholesterol remains hard to control, including those with heterozygous familial hypercholesterolaemia, an inherited condition that can cause high low-density lipoprotein, or LDL, cholesterol.

According to the report, the once-daily pill could offer an alternative to injectable PCSK9 medicines, which are used to reduce “bad” cholesterol in high-risk patients. The approval matters because some patients continue to have elevated LDL levels even after taking standard oral therapies such as maximally tolerated statins. Clinical trial data cited by the newspaper involved 3,207 adults and showed LDL reductions of 56% to 59% over 24 weeks among patients already receiving statins, a level the report said was comparable to injectable PCSK9 treatments.

The Times of India also noted that Lipfendra is not expected to reach India immediately. Dr Subhash Mandal of the Indian Pharmaceutical Association said medicines cleared overseas still require approval from India’s Central Drugs Standard Control Organisation, with clinical trials possible under local rules.

Cardiologists quoted in the report cautioned that the pill is unlikely to become a first-line therapy. Dr Ambuj Roy of AIIMS Delhi said the oral option appears promising for patients who want to avoid injections, while the broader use of such drugs will depend on regulatory clearance, medical guidance and patient suitability.