FDA Approves Higher Dose Shot for Greater Weight Loss

• The FDA has authorised a better dose model of the GLP-1 drug Wegovy for weight reduction.
• The brand new dose is 7.2 milligrams per weekly injection, in comparison with the unique 2.4 milligrams per week.
• The next Wegovy dose may result in larger weight reduction, nevertheless it may include negative effects.

The Meals and Drug Administration (FDA) authorised a brand new, greater dose model of the load loss drug Wegovy on March 19.

This new model, known as Wegovy HD, could have a dosage of seven.2 milligrams, administered weekly by injection. Earlier than the upper dose was authorised, the weekly shot was 2.4 milligrams.

Novo Nordisk developed the upper dose as a result of, whereas the two.4 mg shot has been efficient, “some people don’t attain their therapeutic targets” at that dose, in keeping with a 2025 trial.

“The brand new FDA is transferring with unprecedented effectivity on merchandise that advance nationwide priorities,” stated FDA Commissioner Martin Makary, MD, MPH stated in a press release. “In the present day’s approval is one other demonstration of what the FDA can accomplish after we attempt daring new issues.”

Throughout the STEP UP phase 3b trial in 2025, the upper 7.2 mg dose of Wegovy gave a median weight lack of 18.7%. Round 1 in 3 individuals noticed at the least a 25% weight reduction.

The FDA acknowledged that the upper dose of Wegovy was supported by medical information displaying a security profile in step with the identified negative effects of semaglutide.

“I’m cautiously optimistic,” stated Meghan Garcia-Webb, MD, triple board licensed in inner medication, way of life medication, and weight problems medication. Garcia-Webb wasn’t concerned within the trial.

“This has already been authorised within the E.U. and the U.Okay. General, the security information confirmed that severe adversarial occasions have been really just a little bit decrease for the 7.2 mg group, however as at all times, we must see how this performs out in actual medical apply,” she informed Healthline.

The commonest negative effects of Wegovy embody gastrointestinal results, resembling:

• nausea
• diarrhea
• constipation
• vomiting
• belly ache

Experiences of altered pores and skin sensations, resembling sensitivity, ache, or burning, occurred extra continuously at greater doses of Wegovy.

Nevertheless, these negative effects usually resolve on their very own or with a dose discount.

“Many occasions sufferers could have a flare-up of negative effects once they enhance a dose that subsequently improves over the next weeks to months,” stated Garcia-Webb.

Recent research discovered that there could also be a better danger of ischemic optic neuropathy (ION), or “eye stroke,” with greater doses of Wegovy, particularly in males.

ION may cause sudden imaginative and prescient loss or blindness.

This greater danger could also be due partially to the upper dose, which ends up in larger systemic publicity and quicker weight reduction. This may occasionally have an effect on the blood move to the optic nerve.

“There’s nonetheless loads of analysis to be performed associated to the chance of NAION and semaglutide. It’s smart to be particularly cautious for sufferers who could be taking the very best dose,” stated Garcia-Webb.

“I at all times counsel sufferers to verify their ophthalmologist is OK with them taking semaglutide if they’ve any pre-existing eye situations,” she added.

The FDA’s database depends on voluntary reporting. This implies the numbers don’t mirror how typically the issue really happens.

Nonetheless, the clear sample seen with Wegovy and the upper danger in males means that docs ought to monitor sufferers rigorously, particularly these receiving the upper doses for weight problems.