FDA approves Olumiant for treating some hospitalized COVID-19 patients

[Olumiant image courtesy of Lilly]

The JAK inhibitor Olumiant (baricitinib) from Incyte (Nasdaq:INCY) and Lilly (NYSE: LLY) has scored FDA approval to treat hospitalized COVID-19 patients who need help breathing.

In particular, the new indication covers adult patients needing supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

Olumiant first won FDA approval in 2018 for treating moderately-to-severely active rheumatoid arthritis.

Lilly began testing the drug in hospitalized COVID-19 patients in June 2020. It won emergency use authorization (EUA) for such patients in November of that same year when used with remdesivir.

FDA broadened the EUA in July 2021 to allow its use with or without remdesivir.

Olumiant is the first immunomodulatory therapy to score FDA approval for a COVID-19 indication.

The drug continues to be avail…

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Tremfya shows promise in reducing fatigue in PsA patients

Janssen’s Tremfya (guselkumab) was associated with reduced fatigue in two Phase 3 clinical trials involving 1,120 patients with psoriatic arthritis (PsA), according to an article published in Arthritis Research & Therapy. The study found that PsA patients who received 100 mg of guselkumab every four weeks or every eight weeks had clinically meaningful and sustained improvements in fatigue through one year.

The results offer hope for PsA patients with disease-mediated fatigue — a symptom that doctors have traditionally underappreciated.

To arrive at their conclusion about guselkumab, the investigators used a mediation analysis, a statistical method that attempts to identify the relationship between variables. In this case, the analysis investigated the relationship between fatigue and a variety of PsA symptoms. Such measures included American College of Rheumatology criteria (ACR20) to measure joint improvement, the presence of C-reactive protein to study in…

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