The US Food and Drug Administration (FDA) has granted approval to Lipfendra, an innovative pill for the treatment of hypercholesterolemia. This drug becomes the first oral PCSK9 inhibitor to receive the green light from the regulatory body.

With the imminent loss of Keytruda patents in 2028, Merck reinforces its focus on diversification. Lipfendra represents a new opportunity for the pharmaceutical company, seeking to mitigate the effects of emerging competition in the cancer treatment market.

The FDA's decision was based on two late-stage trials, CNN reports. These showed that the daily pill significantly reduced LDL cholesterol in a wide range of patients, including those with familial hypercholesterolemia and those already taking statins.

Mechanism of action and benefits

Lipfendra works by blocking the PCSK9 protein, thus regulating cholesterol levels in the body. This advancement offers a viable alternative to traditional injectable treatments and improves patients' access to easier management of their condition.

Approximately 25% of adults in the US have high LDL cholesterol. With the arrival of Lipfendra, the cholesterol medication market, which has until now been dominated by injectable options, could see a significant change in its competitiveness and accessibility dynamics.

Patients most indicated for its use

The most appropriate patients to use Lipfendra (enlicitide) are adults with primary hypercholesterolemia (including the genetic form heterozygous familial hypercholesterolemia, HeFH) who are not reaching their LDL cholesterol goals with diet, exercise, and statins at the maximum tolerated dose alone.

Ideal patient profile according to the approved indication

Why this group is the most suitable

Restrictions or contraindications

The available information highlights that Lipfendra does not include specific warnings of contraindications due to hypersensitivity reactions, unlike some injectable PCSK9. However, in general, it is considered contraindicated in people with a known or severe previous allergy to the active ingredient (enlicitide) or to any of the excipients, although this is usually mentioned as a standard precaution in all medications.

Pregnancy and lactation

It is not known whether Lipfendra can harm an unborn baby; It is recommended to inform the doctor if the patient is pregnant, plans to become pregnant or becomes pregnant during treatment.

It is also not known with certainty whether it passes into breast milk; The leaflet indicates that the patient and her health professional should decide the best way to feed the baby and avoid drinking and breastfeeding at the same time without advice.

Use with other medications

It is recommended that you inform your doctor about all medications you take (prescription, over-the-counter, vitamins, and herbal medicines), as there may be potential drug interactions.

This is especially relevant if the patient uses other cholesterol treatments (statins, ezetimibe, etc.), heart drugs, or medications that are metabolized by the same liver pathways.

Taking instructions and practical precautions

One tablet should be taken in the morning on an empty stomach with water, black coffee or simple tea, waiting at least 30 minutes before eating other foods or drinks other than those.

If you forget a dose, it is advisable to take it as soon as you remember, as long as it is at least 30 minutes before the next meal, and not double the dose on the same day.

Common adverse effects and warning signs

In general, side effects in people with high cholesterol are similar to those of those who do not take the medication.

Diarrhea and dizziness have been described more frequently in patients with HeFH, so if these symptoms are intense or persistent, you should consult your doctor.

Lipfendra Estimated Cost

Lipfendra's estimated list price is about $315 for a 30-day supply (about $3,780 a year), putting it clearly below current injectable PCSK9 inhibitors and well above traditional generic statins.

Comparison with injectable PCSK9 inhibitors

Comparison with statins and other oral drugs

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