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Drugs

Icotyde (icotrokinra)

Johnson & Johnson · FDA approval

The first oral peptide that blocks the IL-23 receptor, approved for plaque psoriasis.

Clinical summary

A once-daily oral IL-23 receptor antagonist for moderate-to-severe plaque psoriasis in adults and in children 12 and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. In the head-to-head ICONIC-ADVANCE 1 and 2 trials against deucravacitinib, about 70% of patients reached IGA 0/1 and 55% reached PASI 90 at week 16. It is taken on an empty stomach, at least 30 minutes before eating.

Read the primary source: Johnson & Johnson press release

More innovations

Drugs

Juvmo (tavapadon)

AbbVie · FDA approval

First selective D1/D5 dopamine agonist approved for Parkinson's disease.

A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.

NeurologyView Innovation
Medical Technology

Libre Duo

Abbott · FDA De Novo

First wearable sensor that tracks ketones and glucose together.

A 10-day sensor for people with diabetes aged 2 and older that measures ketones and glucose in interstitial fluid every minute and sends readings, trends and rising-level alerts to a smartphone. Across six clinical studies in more than 600 participants it tracked clinically meaningful ketone differences, including elevated ketones before the onset of diabetic ketoacidosis. Ketone readings should be interpreted with glucose values and symptoms, and do not replace confirmatory testing before treatment decisions.

EndocrinologyView Innovation
Diagnostics

SimpleScreen CRC

Freenome · FDA approval

A second blood-based colorectal cancer screening test reaches the US market.

A cell-free DNA blood test for colorectal cancer screening in average-risk adults aged 45 and older, commercialized in the US by Abbott. In PREEMPT CRC (more than 48,000 participants), sensitivity for colorectal cancer was 81.1% and specificity 90.4%, but sensitivity for advanced precancerous lesions was only 13.7%. A positive result must be followed by colonoscopy, and the test does not replace colonoscopy in high-risk patients.

GastroenterologyView Innovation