The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
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The results of Eli Lilly and Company’s double-blind, placebo-controlled Phase III trials for Olumiant® are encouraging for patients suffering with alopecia.
New data shows Lilly’s Olumiant (baricitinib) significantly reduces the risk of death in hospitalised COVID-19 patients receiving invasive mechanical ventilation or ECMO.
The EMA will conduct an accelerated assessment and issue its decision on whether Olumiant (baricitinib) can be used in hospitalised COVID-19 patients by July.
New Phase III data shows once daily treatment with baricitinib significantly increases hair regrowth in adult patients with severe alopecia areata.
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
A study of baricitinib in combination with remdesivir has met its primary endpoint in COVID-19 patients, by reducing time to recovery in comparison with only remdesivir.
The enterprise announced its drug OLUMIANT® (baricitinib) and an investigational antibody will enter clinical trials in US COVID-19 patients later this month.