Home / Autoimmune Disorders

Autoimmune Disorders

Sanofi Announces FDA Approval of Cablivi, the First Nanobody-Based Medicine for Patients with a Rare Blood-Clotting Disorder

PARIS – February 6, 2019 – The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. “The U.S. approval …

Read More »

Apellis’ APL-2 Receives Orphan Drug Designation from the FDA for the Treatment of Autoimmune Hemolytic Anemia

CRESTWOOD, Ky., and WALTHAM, Mass., Feb. 05, 2019 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat diseases through inhibition of the complement system, today announced that its C3 complement inhibitor, APL-2, has been granted orphan drug designation by the U.S. Food …

Read More »

Arena Reports Positive Long-Term Data from the Open-Label Extension of the Phase 2 Trial Evaluating Etrasimod in Ulcerative Colitis

SAN DIEGO, Jan. 7, 2019 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data from the open-label extension (OLE) of the Phase 2 OASIS trial of its investigational drug candidate etrasimod, a next-generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator in development for the treatment of moderate to severely active ulcerative …

Read More »

Lilly and Aduro Biotech Announce Research Collaboration and License Agreement to Develop Novel Immunotherapies

INDIANAPOLIS and BERKLEY, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) — Eli Lilly and Company (NYSE: LLY) and Aduro Biotech, Inc. (NASDAQ: ADRO) today announced a research collaboration and exclusive license agreement for Aduro’s cGAS-STING Pathway Inhibitor program for the research and development of novel immunotherapies for autoimmune and other inflammatory …

Read More »

FDA Approves Amgen’s Nplate for Use in Pediatric Patients with Immune Thrombocytopenia

THOUSAND OAKS, Calif., Dec. 14, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Nplate®(romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient …

Read More »

FDA Grants Fast Track Designation to Lilly’s Baricitinib for the Treatment of Systemic Lupus Erythematosus

INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The Fast Track designation process aims to facilitate the development and …

Read More »

FDA Approves Catalyst’s Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome

CORAL GABLES, Fla., Nov. 29, 2018 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Firdapse® (amifampridine) 10 mg tablets for the treatment of …

Read More »

FDA Approves ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for Treatment of RA, GCA and Two Forms of Juvenile Arthritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active …

Read More »

Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis

THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …

Read More »

Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet

CHICAGO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR …

Read More »