Tags : Moderate-to-Severe

LEO Pharma Receives the US FDA’s Fast Track Designation for

Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions […]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

Pfizer and Eli Lilly Report the US FDA Acceptance of

Shots: The US FDA has accepted to review a BLA for tanezumab (2.5 mg, SC), being evaluated for patients with chronic pain due to mod. to sev. OA with inadequate pain relief with other analgesics The regulatory submission is based on data from 39 P-I-III clinical studies assessing tanezumab in 18,000 patients, including three P-III […]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 SURE Study

Shots: The P-III BE SURE study involves assessing bimekizumab vs AbbVie’s Humira (adalimumab) in 478 patients with chronic PSO for at least 6mos. prior to screening with an affected body SA of at least 10%, PASI of at least 12 and IGA score ≥3 The P-III BE SURE study result: met its co-1EPs @16wks. ie, […]Read More