Deucravacitinib

Eli Lilly's Olumiant and Pfizer's Litfulo Strengthen Alopecia Areata Arsenal, Yet Resounding Opportunity for JAK Expansion and New Assets in Development Remain

Retrieved on: 
Wednesday, November 15, 2023

Despite this, Olumiant is anticipated to maintain a substantial lead over Litfulo in the market.

Key Points: 
  • Despite this, Olumiant is anticipated to maintain a substantial lead over Litfulo in the market.
  • Prescribers of both brands express high and comparable satisfaction levels, far surpassing the satisfaction rates associated with non-advanced systemic treatment options.
  • Recent data from Spherix's published studies highlight minimal differentiation among prescribers regarding the two JAK inhibitors.
  • Furthermore, barriers preventing increased use of either JAK inhibitor remain closely contested, with safety concerns topping the list for each asset.

Recludix Pharma Presents Preclinical Data Demonstrating Strong Efficacy and Favorable Safety Profile of REX-7117 Versus TYK2 and JAK Inhibitors at the Dermatology Drug Development Summit

Retrieved on: 
Tuesday, October 31, 2023

SAN DIEGO, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in platform approaches to discover inhibitors of challenging targets for inflammatory disease and cancer, announced that in a presentation given today at the 7th Annual Dermatology Drug Development Summit titled “Finding the New Ground Between Safety & Efficacy in Drug Development,” Recludix’s senior vice president of biology, Paul Smith, Ph.D., reviewed the challenges associated with inhibition of the JAK/STAT pathway through TYK2 and JAK inhibitors and presented preclinical data with Recludix’s STAT3 inhibitor REX-7117, which potently and selectively targets the STAT3 Src Homology 2 (SH2) domain. The presentation is available on the company’s website under the section titled “Events.”

Key Points: 
  • “Importantly, other approaches to inhibiting the JAK/STAT pathway by targeting TYK2 or JAK have resulted in undesirable safety consequences, such as increased risk of infections or altered hematopoiesis.
  • It provides durable STAT3 inhibition and maintains in vivo selectivity against other STAT proteins, even after the administration of multi-day oral dosing in a preclinical model.
  • In a translational Th17 preclinical model of psoriasis, once daily REX-7117 (300 mg/kg) was superior to a clinically-relevant dose of deucravacitinib (1 mg/kg).
  • Moreover, twice daily REX-7117 (300 mg/kg) was comparable to deucravacitinib at a supra-clinical dose (30 mg/kg), reinforcing the rationale of STAT3 targeting as a potential disease-modifying opportunity.

Sotyktu (deucravacitinib) Long-Term Data Demonstrate Durable Efficacy and Consistent Safety for up to Three Years in Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Wednesday, October 11, 2023

Bristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • Bristol Myers Squibb (NYSE:BMY) today announced new three-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.
  • Sotyktu demonstrated a consistent safety profile with no increases in the rates of adverse events (AEs) or serious AEs over time, and no emergence of any new safety signals.
  • The efficacy analysis assessed 513 patients who received continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1 and POETYK PSO-2 trials and transitioned to the LTE trial.
  • “These new data validate the potential of Sotyktu to provide long-term, clinically relevant improvement for individuals living with moderate-to-severe plaque psoriasis.”
    Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.

With Little Remaining Unmet Need for Injectable Biologics for the Treatment of Plaque Psoriasis, US Dermatologists Report the Future is Oral, According to Spherix Global Insights

Retrieved on: 
Thursday, August 31, 2023

With the entry of each next generation biologic, the standards of care and expected bar of performance have continually expanded.

Key Points: 
  • With the entry of each next generation biologic, the standards of care and expected bar of performance have continually expanded.
  • In fact, US dermatologists in Spherix Global Insights’ RealTime Dynamix™: Plaque Psoriasis Q3 update estimate overall patient share for the legacy oral asset is nearly double that of Sotyktu.
  • When probed specifically on what, if any, remaining needs exist, it is clear the future is oral.
  • Spherix also captured where in the treatment algorithm assets such as JNJ-2113 would fit and will continue to track the evolving pipeline opportunities via it’s RealTime Dynamix™: Plaque Psoriasis service.

Bristol Myers Squibb Launches Clear Understanding Campaign to Reveal the Plain Truth About Living with Moderate to Severe Plaque Psoriasis

Retrieved on: 
Tuesday, August 8, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230804756518/en/
    Nitika, living with moderate to severe plaque psoriasis.
  • (Photo: Bristol Myers Squibb)
    “I was young when I was diagnosed with moderate to severe plaque psoriasis, and it felt like my whole life revolved around my condition.
  • “This insight drove us to launch the Clear Understanding campaign to recognize those concessions and encourage people living with moderate to severe plaque psoriasis to talk to their dermatologist about available treatment options."
  • In two studies of moderate to severe plaque psoriasis, Sotyktu was compared to placebo and Otezla® (apremilast).

Cutaneous Lupus Erythematosus Market Insight & Forecast Reveals USD 1.2 Billion Growth Potential by 2032 - ResearchAndMarkets.com

Retrieved on: 
Monday, July 31, 2023

The "Cutaneous Lupus Erythematosus Market Insight, Epidemiology And Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cutaneous Lupus Erythematosus Market Insight, Epidemiology And Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • In 2022, the Cutaneous Lupus Erythematosus market in the 7MM and China was approximately USD 580 million, expected to reach USD 1.2 billion by 2032.
  • Notably, Biogen's litifilimab and Bristol Myers Squibb's deucravacitinib will lead the Cutaneous Lupus Erythematosus market in the forecast period.
  • In 2022, the total market size of Cutaneous lupus erythematosus in the 7MM and China was ~USD 580 million, expected to reach ~USD 1,260 million by 2032.

Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib), a Once-Daily Oral Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Tuesday, March 28, 2023

The POETYK study program demonstrated a consistent safety profile in patients through three years of continuous treatment.

Key Points: 
  • The POETYK study program demonstrated a consistent safety profile in patients through three years of continuous treatment.
  • “Today’s approval is a landmark achievement as patients across Europe with moderate-to-severe plaque psoriasis will now have the opportunity to be treated with Sotyktu, the first once-daily oral option to provide significant symptom relief,” said Samit Hirawat , MD, chief medical officer, Bristol Myers Squibb.
  • Up to 90% of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales.
  • The majority of infections were non-serious and mild to moderate in severity and did not lead to the discontinuation of Sotyktu.

Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu (deucravacitinib) as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

Retrieved on: 
Friday, January 27, 2023

Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis.
  • Sotyktu, an oral medication taken once-daily, is a first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
  • The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
  • Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program.

Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency

Retrieved on: 
Monday, November 29, 2021

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.
  • These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
  • Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla.
  • Deucravacitinib was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities.

Bristol Myers Squibb Data at ACR Convergence 2021 Illustrate Scientific Advances for Immune-Mediated Rheumatic Diseases

Retrieved on: 
Wednesday, November 3, 2021

These data reinforce Bristol Myers Squibbs commitment to developing new treatments for rheumatic diseases.

Key Points: 
  • These data reinforce Bristol Myers Squibbs commitment to developing new treatments for rheumatic diseases.
  • Bristol Myers Squibb-sponsored abstracts that will be presented at the ACR Convergence 2021 can be found below.
  • Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on rheumatic diseases.
  • In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.