Company: AstraZeneca, Merck
Crisaborole 2% ointment
Trade Name: Eucrisa®
Approval Dates/Comments: In March 2020, the FDA approved a supplemental new drug application to expand the indication of crisaborole to include treatment of mild-to-moderate atopic dermatitis (AD) in children ages 3 months to 24 months. Crisaborole is a topical phosphodiesterase-4 inhibitor that was previously approved in 2016 for patients aged ≥2 years. This new approval was based on the Phase 4 CrisADe CARE 1 study, a 4-week, multicenter, open-label, single-arm trial investigating the safety of twice daily crisaborole 2% use. There were 137 pediatric patients aged 3 months to <24 months who had mild-to-moderate AD involving at least 5% of BSA, excluding the scalp. The study found that the drug was well tolerated and effective with no difference in safety outcome compared with previous studies.
Infliximab biosimilar for IV injection
Trade Name: Avsola™
Company: Amgen Canada
Approval Dates/Comments: Health Canada approved this anti-tumor necrosis factor-alpha monoclonal antibody in March 2020 for all approved indications of the reference product, Remicade® (infliximab), including chronic severe plaque psoriasis and psoriatic arthritis.
Trade Name: Olumiant®
Company: Eli Lilly and Company, Incyte Corporation
Approval Dates/Comments: The FDA granted Breakthrough Therapy designation in March 2020 for baricitinib for alopecia areata (AA). Baricitinib is a oncedaily, oral Janus kinase inhibitor approved in the US under the brand name Olumiant® to treat moderate-to-severe rheumatoid arthritis. The expedited status is based on the positive Phase 2 results of the adaptive Phase 2/3 study BRAVE-AA1, which evaluated treatment with baricitinib vs. placebo in adults with AA. In the Phase 2 portion of the BRAVE-AA1 study up to Week 36, there were no new safety signals with no serious adverse events reported. The reported treatment-emergent adverse events were mild or moderate and the most common included upper respiratory tract infections, nasopharyngitis, and acne. Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 double-blind study (BRAVE-AA2) are currently assessing the efficacy and safety of the 2 mg and 4 mg doses of baricitinib vs. placebo.