Here’s a brief look at 6 medications for rheumatologic disorders that were newly approved in the second half of 2018.
Here’s a brief overview of 6 medications for rheumatologic disorders that were approved or granted a new indication or an additional formulation in the second half of 2018.
RA/Giant Cell Arteritis/JIA: ACTPen (tocilizumab), a single-dose prefilled autoinjector for Actemra, was approved as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs, and for adult patients with giant cell arteritis. Furthermore, the ACTPen can be administered by caregivers to patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). (Approved 11/26/2018, Genentech)
Lambert-Eaton Myasthenic Syndrome: Firdapse (amifampridine), a nonspecific, voltage-dependent, potassium channel blocker, is indicated for the treatment of Lambert Eaton myasthenic syndrome (LEMS), a rare autoimmune disease, in adults. (Approved 11/28/2018, Catalyst Pharmaceuticals, Inc.)
Plaque Psoriasis: Bryhali Lotion (halobetasol propionate), is a potent to superpotent corticosteroid indicated for the topical treatment of plaque psoriasis in adults. (Approved 11/6/2018, Ortho Dermatologics)
Primary Hemophagocytic Lymphohistiocytosis (HLH): Gamifant (emapalumab) is the first drug approved by the FDA specifically for HLH. It is indicated for the treatment of pediatric (newborn and older) and adult patients with primary HLH who have refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy. (Approved 11/20/2018, Novimmune SA)
Uveitis: Yutiq (fluocinolone acetonide intravitreal implant) was approved for the treatment of chronic non-infectious uveitis that affects the posterior segment of the eye. (Approved 10/15/2018, EyePoint Pharmaceuticals, Inc.)
For more information, please see Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis Gets FDA Nod.
RA/JIA/PsA/AS/Crohn’s/UC/Psoriasis: Hyrimoz (adalimumab-adaz) is a biosimilar for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in patients 4 years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. (Approved 10/31/2018, Sandoz, a Novartis division)