Weekly Top News – Psoriasis – February 3, 2020

February 3, 2020

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission in US/EU for juvenile PsA in H2 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results 


Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory submission in US for pediatric psoriasis in 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results: Regulatory submission for psoriatic arthritis (head to head) in 2020; Regulatory submission for ankylosing spondylitis in 2024 or later 


Otezla (apremilast) / Amgen
Otezla: PDUFA action date for scalp psoriasis in April 2020 (Amgen) – Jan 31, 2020 – Q4 2019 Results 


Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory decision in China for ankylosing spondylitis in H1 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results: Regulatory decision in EU for pediatric psoriasis in H2 2020 


ANB019 / AnaptysBio
ANB019: Top-line data from P2 POPLAR trial (NCT03633396) for palmoplantar pustulosis in H2 2020 (38th Annual J.P. Morgan Healthcare Conference, AnaptysBio) – Jan 28, 2020 


Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
Cimzia (certolizumab pegol) now available for patients in Japan living with multiple psoriatic diseases (UCB Press Release) – Jan 28, 2020 – “UCB announced today that it received approval from Japanese health authorities for CIMZIA® (certolizumab pegol) to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma for which existing treatment methods are not sufficiently effective. The approval makes CIMZIA the first Fc-free, PEGylated anti-TNF treatment option now available for these patients in Japan….For the newly approved indication of CIMZIA for psoriasis, UCB Japan will be conducting all promotional activities, thus expanding its dermatology footprint to Japan.”


Xeljanz (tofacitinib) / Pfizer; abrocitinib (PF-04965842) / Pfizer; PF-06700841 / Pfizer; PF-06826647 / Pfizer
Pfizer reports fourth-quarter and full-year 2019 results (Businesswire) – Jan 28, 2020 – “In the first half of 2020, we expect to report pivotal top-line results for the JADE Compare study for abrocitinib (PF-04965842), our Janus kinase-1 (JAK1) inhibitor for moderate-to-severe atopic dermatitis…for Xeljanz in ankylosing spondylitis….We also expect data in the first half of 2020 for promising earlier-stage opportunities, including proof-of-concept readouts for PF-06939926…for Duchenne muscular dystrophy…and for PF-06700841, an investigational topical TYK2/ JAK1 dual inhibitor for psoriasis and AD….In the second half of 2020, we look forward to top-line results for…PF-06700841 for potential treatment of psoriatic arthritis (PsA), and for PF-06826647, our investigational TYK2 inhibitor for psoriasis.”


Cosentyx (secukinumab) / Novartis
Cosentyx: Expiry of composition-of-matter patent in EU/Japan in 2025 and US in 2026 with patent term extensions in US until 2029 and Japan between 2026-2028-2029 (Novartis) – Feb 2, 2020 – Annual Report 2019: Regulatory data protection in US until 2027, EU until 2026 and Japan until 2022; SPC in EU until 2030


Cosentyx (secukinumab) / Novartis
Cosentyx: Expiry of patents on method of use for psoriasis in US in 2032 and EU/Japan in 2031 with patent term extension in Japan in 2032-2033 (Novartis) – Feb 2, 2020 – Annual Report 2019: Expiry of patent on method of use for AS in US in 2033 and psoriatic arthritis in Japan in 2031; Pediatric exclusivity in EU until 2030


Stelara (ustekinumab) / J&J
Anvisa approves new indication for ustequinumab, from Janssen, for the treatment of psoriasis in children and adolescents [Google Translation] (PRNewswire) – Jan 27, 2020 – “Janssen…announces that Anvisa has approved, in fast track – accelerated drug registration, STELARA® (ustequinumab) for the treatment of psoriasis in moderate to severe plaque in pediatric patients aged 6 to 17 years. Brazil was the first country to register the approval of ustequinumab for the age group of 6 to 11 years – a population in need of safe and effective treatment options….Janssen announced that it made the same submission to the US Food and Drug Administration (FDA) in October 2019, and the regulatory review is in process.”

No Comments

Post a Comment