Belimumab for IV use
Trade Name: Benlysta
Company: GSK
Approval Dates/Comments: In April 2019, the US FDA expanded the label for belimumab, a B-lymphocyte stimulator (BLyS)-specific inhibitor, to include use in children with lupus from as young as 5 years of age. The approval extends the current indication in the US for the IV formulation of Benlysta in adults, to patients aged ≥5 years of age with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Etanercept-ykro
Trade Name: Eticovo™
Company: Samsung Bioepis
Approval Dates/Comments: The FDA approved this biosimilar referencing etanercept (Enbrel®) in April 2019 across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis.
Halobetasol propionate 0.01% + tazarotene 0.045% lotion
Trade Name: Duobrii™
Company: Bausch Health
Approval Dates/Comments: In April 2019, the FDA approved Duobrii™ lotion for the topical treatment of plaque psoriasis in adults. This is the first and only topical lotion that contains a combination of halobetasol propionate (corticosteroid) and tazarotene (retinoid) in one formulation. Phase 3 studies demonstrated after 8 weeks of therapy 45% of patients using the combination lotion had “clear” or “almost clear” skin vs. 13% of placebo.
Protein replacement therapy
Trade Name: PTR-01
Company: Phoenix Tissue Repair
Approval Dates/Comments: In April 2019, the FDA granted Fast Track designation for PTR-01, an investigational protein replacement therapy designed to treat recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a rare genetic disorder associated with severe skin blistering and treatment is currently limited to palliative options. PTR-01 uses a recombinant collagen type VII (rC7) for the treatment of RDEB and is administered intravenously. It works by replacing defective collagen type VII with healthy collagen.
Risankizumab for SC injection
Trade Name: Skyrizi™
Company: AbbVie
Approval Dates/Comments: In April 2019, the FDA granted Fast Track designation for PTR-01, an investigational protein replacement therapy designed to treat recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a rare genetic disorder associated with severe skin blistering and treatment is currently limited to palliative options. PTR-01 uses a recombinant collagen type VII (rC7) for the treatment of RDEB and is administered intravenously. It works by replacing defective collagen type VII with healthy collagen.
Ruxolitinib tablets
Trade Name: Jakafi®
Company: Incyte Corporation
Approval Dates/Comments: The FDA approved an additional indication for ruxolitinib (a JAK1/JAK2 inhibitor) in May 2019 for the treatment of steroidre-fractory acute graft-versus-host disease (GVHD) in adult and pediatric patients ≥12 years of age. The approval marks the first FDA-approved treatment for this indication.
Oral MEK inhibitor
Trade Name: PD-0325901
Company: SpringWorks Therapeutics
Approval Dates/Comments: In June 2019, the FDA granted Fast Track designation for PD-0325901, an investigational, oral, small molecule inhibitor of MEK1 and MEK2, for the treatment of patients ≥2 years of age with neurofibromatosis type 1-associated inoperable plexiform neurofibromas that are progressing or causing significant morbidity.
