2 weeks ago
FDA-approved oral pill Lipfendra could change bad cholesterol treatment
A new medicine called Lipfendra is a small pill that lowers 'bad' cholesterol.
For a long time, the strongest medicines for this worked only as shots, which some people do not like.
Lipfendra is the first pill version of this kind of medicine, called a PCSK9 inhibitor.
The FDA, the agency in the United States that checks medicines, recently approved it.
Studies show the pill can lower bad cholesterol by nearly 60 percent, just like the shots.
Doctors say a pill is easier to take and easier for family doctors to give out.
Some doctors in India hope the drug will come to India and may even be made there cheaply.
But the drug is not approved in India yet, and doctors warn it may still be too expensive for many people.
Doctors also say the pill is not a cure-all, and healthy eating, exercise and early cholesterol check-ups still matter.
The US FDA approved Lipfendra, a once-daily pill that lowers LDL ('bad') cholesterol.
It is the first tablet version of a PCSK9 inhibitor, a class previously available only as injections.
Clinical studies show Lipfendra can reduce LDL cholesterol by nearly 60%, comparable to injectable PCSK9 inhibitors.
Experts say the pill removes barriers such as needle aversion, cold-chain storage and repeated administration, but warn it does not solve the price barrier.
The drug is not yet approved in India; availability would depend on CDSCO approval and pricing, with local manufacturing suggested.
- Who
- The US FDA approved Lipfendra, developed by Merck (MSD); Indian doctors including Dr Vishal Khullar, Dr Amit Kumar Malik, Dr TS Kler and Dr SK Wangnoo commented on its impact.
- What
- Approval of Lipfendra, a once-daily oral PCSK9 inhibitor pill that lowers LDL ('bad') cholesterol by nearly 60%.
- Where
- The United States, with potential future availability in India under discussion.
- When
- Recently, via US FDA approval; the exact approval date is not stated in the articles.
- Why
- To offer a more convenient oral alternative to injectable PCSK9 inhibitors, improving treatment access, acceptance and adherence.
Oral pill's convenience
Caution on adherence and price
Adherence: daily pill vs periodic injection
Oral pill's convenience
Dr Malik says an oral option improves convenience, treatment acceptance and long-term adherence, especially among patients reluctant to take injections.
Caution on adherence and price
Dr Khullar notes daily pills often fall by the wayside beyond the first year, while a six-monthly injection guarantees protection for that interval.
Availability and cost in India
Oral pill's convenience
Dr Kler prefers Indian companies manufacturing the drug locally, saying it would make it more affordable and that many patients would switch from injections if the price is reasonable.
Caution on adherence and price
Dr Khullar warns the pill removes the needle but not the price barrier, and Dr Wangnoo says it is too early to comment on any specific product or manufacturer for India.
Key facts
- Drug name
- Lipfendra
- Regulator
- US Food and Drug Administration (FDA)
- Drug class
- Oral PCSK9 inhibitor (first tablet form)
- LDL reduction
- Nearly 60% in clinical studies
- Previous options
- Injectable PCSK9 inhibitors (evolocumab, alirocumab)
- Approved indication
- High LDL cholesterol, including familial hypercholesterolaemia
- India status
- Not yet approved; would require CDSCO approval
- Dyslipidaemia in India
- About 81% of adults screened (ICMR-INDIAB study)
Quotes
Dr Amit Kumar Malik
Director, interventional cardiology and electrophysiology, Medanta Noida
“An oral medicine has several practical advantages. Unlike injections, it does not require refrigeration or specialised administration, making it easier to prescribe, distribute, and use in routine clinical practice. If these factors are favourable, wider adoption among high‑risk patients is possible.”
financialexpress.com
“Daily tablets are generally easier to incorporate into routine life than periodic injections. Removing the needle solves one barrier, but price remains a challenge.”
financialexpress.com
Sources
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