Keythera (Suzhou) Pharmaceuticals Co. Ltd. has divulged new tyrosine-protein kinase JAK3 inhibitors reported to be useful for the treatment of alopecia areata, rheumatoid arthritis, lupus erythematosus, inflammation, allergy, cancer, metabolic diseases and transplant rejection, among other disorders.
Chiesi Farmaceutici SpA has synthesized Janus kinase inhibitors, particularly JAK1, JAK2, JAK3 and nonreceptor tyrosine-protein kinase TYK2 inhibitors, reported to be useful for the treatment of asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis and acute respiratory distress syndrome.
Eli Lilly and Co. crossed the line in front of three strong competitors with the U.S. FDA’s approval of Olumiant (baricitinib) as a first-in-disease systemic treatment for severe alopecia areata. Two of those three are, like Olumiant, JAK inhibitors and have recent phase III data to run by the FDA.
Concert Pharmaceuticals Inc. is on track for an NDA filing for CTP-543 in alopecia areata during the first half of 2023, following a positive read-out from the first of two phase III trials of the oral Janus kinase 1/2 inhibitor. The molecule hit the primary endpoint of the placebo-controlled Thrive-AA1 study, which was defined as the percentage of patients achieving a SALT (Severity of Alopecia Assessment Tool) score of 20 or less after 24 weeks of therapy.
Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%.
Pfizer Inc. is to buy Arena Pharmaceuticals Inc. for $6.7 billion, adding a potential follow-up to inflammatory diseases pill Xeljanz (tofacitinib) to its pipeline plus several other potential medicines targeting gastroenterology, dermatology and cardiology.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) joined the JAK inhibitor pile-on Oct. 6 with new measures to reduce the risk of major heart problems and malignancies in people taking Pfizer Inc.’s Xeljanz (tofacitinib).
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib).
