Tags : Plaque Psoriasis

UCB Reports the FDA’s and EMA’s Acceptance of BLA and

Shots: The marketing application submissions are based on three P-III studies- BE VIVID, BE READY, BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO All 3 P-III studies met their 1EPs, demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured […]Read More

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study

Shots: The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg […]Read More

Amgen Reports Results of Otezla (apremilast) in P-III ADVANCE Study

Shots: Shots: The P-III ADVANCE study involves assessing of Otezla (apremilast, 30mg, bid for 16wks.) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis. Later, patients will receive Otezla during an open-label extension phase @32wks. The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, […]Read More

Eli Lilly’s Taltz (ixekizumab) Receives the US FDA’s Approval for

Shots: The approval is based on P-III study assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO in 171 patients aged 6-18 yrs. with mod. to sev. PsO who are candidates for systemic therapy or phototherapy The P-III study results: patients achieving PASI 75 (89% […]Read More

Amgen Receives Health Canada’s Marketing Authorization Transfer of Otezla for

Shots: Health Canada’s marketing authorization transfer of Otezla from Celgene follows Amgen’s acquisition of the global rights of Otezla completed in Nov’2019 The addition of Otezla bolster Amgen’s portfolio of innovative biologics and biosimilar products and complements its expertise in mod. to sev. PsO and active PsA Otezla is a selective PDE4 inhibitor, inhibiting the […]Read More

UCB Reports Results of Bimekizumab in P-III BE VIVID Study

Shots: The P-III BE VIVID study involves assessing of Bimekizumab vs PBO & Ustekinumab in 570 patients with chronic plaque psoriasis for at least 6mos. prior to screening and with an affected body surface area of at least 10% and PASI of at least 12 The P-III BE VIVID study results: @16wks. met its co-1EPs […]Read More