Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots:

  • The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis
  • The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score
  • Otezla is a selective PDE4 inhibitor, approved therapy for mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy, for active PsA, and for with oral ulcers associated with Behçet’s Disease

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Conejo Valley Guide

The post Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis first appeared on PharmaShots.

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

Shots:

  • The P-III POETYK PSO-2 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) in 1,020 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported results
  • Deucravacitinib is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Click here ­to­ read full press release/ article | Ref: BMS | Image: Dallas Morning News

The post BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis first appeared on PharmaShots.

MC2 Therapeutics Wynzora Cream Receives the US FDA’s Approval to Treat Plaque Psoriasis in Adults

  • The approval is based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older
  • The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score at @4wks. 60.3% vs 21.4%
  • Wynzora is a novel topical solution offering high efficacy, favorable safety and excellent and is filled for MAA application in EU

Click here ­to­ read full press release/ article | Ref: MC2 Therapeutics | Image: MC2 Therapeutics

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

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 secukinumab @ 0, 1, 2, 3, 4wks. followed by 300mg, q4w starting @4wks.; PBO @ 0, 4, 8, 12 wks. followed by 250mg mirikizumab q4w starting @16wks. through 32wks. followed by q8w thereafter
  • Results: @16wks. sPGA(0,1) (79.7% vs 6.3% & 76.3%), PASI 90 (74.4% vs 6.3% & 72.8%); PASI 100 (37.7% vs 1.8% & 36.6%). In general, the study resulted in meeting its 1EPs and all key 2EPs vs PBO @16wks. and all key 2EPs vs Cosentyx (secukinumab) @16wks. (non-inferiority) and @52wks. (superiority)
  • Mirikizumab is an IgG4 mAb binding p19 subunit of IL-23 and being evaluated for immune diseases, including psoriasis, UC and CD

Click here to read full press release/ article | Ref: Eli Lilly | Image: Glassdoor