Welcome to your Regulatory Index News digest. Today we have reports of a FDA approval for a smallpox therapy, a FDA re-submission for an osteoporosis drug and a share price boost for an Italian biotech.
First smallpox therapy approval by FDA
Naturally occurring smallpox, the contagious, disfiguring and often deadly disease is deemed eradicated, however fears of it being used as a biological warfare agent persist. The FDA has approved TPOXX (tecovirimat), also known as ST-246, as the first treatment designed to mitigate the impact of a potential outbreak of smallpox caused by bioterrorism. It is available as an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. Please click here to read more on this from a PharmaTimes article.
Evenity, the osteoporosis drug by UCB and Amgen is resubmitted in the US
Following an initial rejection in July 2017, UCB and Amgen have approached US regulators for review of their bone-boosting drug Evenity (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Further safety and efficacy data from the Phase lll active-comparator ARCH study and the BRIDGE study (testing Evenity in men with osteoporosis) was asked for in the FDA's Complete Response Letter, which is now contained in the re-submission. Evenity is also under review in Europe. Please click here to read more on this from a PharmaTimes article.
Cassiopea's hair loss drug clascoterone shows promise in alopecia
Share prices for the small Italian biotech company Cassiopea have been boosted by more than 90% since 9th July following the successful results for clascoterone in alopecia. Their ongoing Phase 2 trial of clascoterone in alopecia is offering investors further confidence following the results found in acne - in a different formulation and strength - last week. Cassiopea tested four dose regimens of the drug against a vehicle comparator in their 404-subject study, with six-month results from 375 participants showing treatment with all four doses led to a statistically significant change from baseline in target area headcount (TAHC). Assuming the results are positive after 12 months, Cassiopea intends to take clascoterone into Phase 3 testing for alopecia, with a 2021 approval forecast. Please click here to read more on this from a BioPharmaDive article.