Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN.
Aclaris Therapeutics Inc. CEO Neal Walker said “a lot of room within rheumatoid arthritis [RA]” remains for new drugs, such as his firm’s orally delivered ATI-450. “We see opportunities given the profile, the relative efficacy and safety that we've already demonstrated, to look at not only potentially monotherapy or earlier treatment of disease but also combo treatment, particularly given the safety profile. I think it's pretty well-known that polypharmacy is the rule in this indication.”
Evoq Therapeutics LLC, a Michigan-based company developing a new technology for treating autoimmune disease, has signed a new license and collaboration agreement giving Amgen Inc. exclusive rights to selected programs in the area, undisclosed in number and indication. Valued at more than $240 million in up-front and milestone payments, the deal also includes potential royalties on sales of resulting therapies, Evoq said.
DUBLIN – Sanofi SA is paying $1.1 billion up front and up to $350 million more in potential clinical development and regulatory milestones to acquire antibody developer Kymab Ltd. The deal adds to Sanofi’s pipeline first-in-class OX40-ligand blocker KY-1005, which recently hit the primary endpoints of a phase IIa trial in atopic dermatitis, as well as a second clinical-stage asset, KY-1044, an ICOS agonist in development for solid tumors. It also brings Sanofi a new antibody discovery platform, comprising several transgenic mouse strains, which collectively encode all the building blocks required to produce fully human antibodies.
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