Representative image 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.CJP Jantar Mantar Protest UpdatesDharmendra Pradhan resigns as Union education minister amid massive student protests’We won’t go’: CJP’s Dipke says protests to continue till all demands metFresh clashes at Jantar Mantar after Pradhan’s exit; tear gas fired, stones peltedThe 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.Get the latest India News and Live updates. Download the TOI app.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosPM Modi Sets Up Exam Reform Task Force Under Infosys Co-Founder Nandan Nilekani After NEET Backlash‘Eating Chicken On Ganga River Is Not An Offence’: Supreme Court Judge Slams Arrests Over BiryaniAssam Floods: Death Toll Climbs to 66; BJP Launches ₹12 Crore Relief Campaign’Did You Approve This?’: Rahul Gandhi BLASTS Amit Shah Over ‘Barbaric Assault’ On Student Protesters’Don’t Cry Later’: Asaduddin Owaisi Makes Alliance Offer To Akhilesh Yadav To Oust BJP In UP PollsDelhi Drain Tragedy: 20-Year-Old US Student Dies After Car Plunges Into DrainKargil Vijay Diwas 2026: How Operation Vijay Transformed India’s Military And Defence Strategy3 Arrested In Assam As STF Cracks Down On Alleged Pakistan-Linked Sleeper Cell NetworkDelhi Approves Rs 6,970-Crore Tunnel Corridor To Cut Airport, Mahipalpur Traffic‘Time To Go Home’: CJP Removes Stage, Urges Protesters To Leave Jantar Mantar123Photostories“Hum bread bhi nahi le sakte, hum doodh bhi nahi le sakte…”: CWG 2026 Gold medalist Mirabai Chanu on her diet and the reason behind itThese 5 viral relationship myths may be ruining your love life”They had..in the afternoon and with veggies and sambar in the evening”: R Madhavan reveals his grandparents’ staple food they ate till the age of 82; 6 South Indian ways to include it in your dietThe country that inspired the Mediterranean diet is now battling a childhood obesity crisis. What went wrong?Before you throw away coconut shells, try these 7 clever garden ideas insteadOptical illusion personality test: What you spot first in this picture tells how you approach problems in your life (there is a bonus hidden too)Why Red Wine should always be allowed to breathe before drinking—this is what happens inside the bottle and the glassThinking of dating a coworker? These 8 rules can save your relationship and your career“Talk to your baby as if they understand you”: Pediatrician shares 5 simple habits that may support your baby’s brain development5 natural foods that can kill cockroaches instantly123Hot PicksSchool holiday todayDelhi metroCJP ProtestMumbai rainGujarat RainAIIMS notificationNEET paper controversyAAI recruitment 2026Caitline ClarkTop TrendingMP NEET Arpirant RapeNEET Paper LeakCJP Protester AssaultedKerala IPS Ajith Kumar SuspensionAssam Flood DeathsDelhi Metro Stations ClosedMumbai ProtestUP Amroha WeddingHarbhajan singhIND U19 vs Sri Lanka U19
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.
CJP Jantar Mantar Protest Updates
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.
