Top Quality Pharmaceutical Material Baricitinib With Safe Pass

Beschreibung

In February 2017 Baricitinib was approved for use in the EU as a second-line therapy for moderate to severe active rheumatoid arthritis in adults, either alone or in combination with methotrexate.

Baricitinib received a CRL from the FDA in April, 2017. The letter indicated that the FDA was unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses and that additional data is necessary to further characterize safety concerns across treatment arms.

On 23 April, 2018, an FDA Advisory Committee recommended approval of baricitinib 2mg for the treatment of rheumatoid arthritis but did not recommend the 4mg dose, citing serious adverse events.On 31 May 2018 FDA approved Barictinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.