The drug, branded as Litfulo, has been approved by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for people aged 12 years and older suffering from severe alopecia areata.
CAR-T cell therapy, or chimeric antigen receptor T cell therapy, is best known for its application in oncology, where the results have been life-changing for patients. The therapy for autoimmune diseases made headlines in September 2022 when five patients with systemic lupus erythematosus (SLE) were confirmed to be in remission for an average of eight months after treatment.
Last year CDER approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in its annual New Drug Therapy Approvals report. The agency also approved drugs in new settings, such as for new uses and patient populations.
While acquiring Horizon would add a mixed portfolio of specialty drugs to Sanofi’s roster, it would not address the French company’s need to develop its drug pipeline and improve its productivity from research and development, analysts say.
Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.
Horizon Therapeutics achieved third place in the 2022 OCI top companies ranking namely for its “Gout Revisited” campaign, which seeks to remove the stigma of gout, a disease that has been largely coined as an affliction of the “overindulgent, rich white man.” Keli Walbert, executive vice president, U.S. Operations, at Horizon Therapeutics shared insights with MedAdNews about the company’s strategy in debunking gout myths and steering the message in the right direction.
The top performers among drugs launched in 2020 were each the first of their kind.
MiroBio and Gilead believe they can offer new, best-in-class assets to patients beset by different autoimmune diseases. The deal includes MiroBio’s lead investigational candidate, MB272, a selective agonist of T, B and dendritic cells that aims to inhibit or blunt activation and suppress an inflammatory immune response.
Weeks after announcing a significant partnership with Evotec to advance treatment for type 1 diabetes, Canada-based Sernova Corp. shared positive Phase I/II data from an ongoing clinical study of the company’s implantable Cell Pouch device that showed evidence of in vivo active insulin production following implantation of the device and islet transplantation.