Upper respiratory tract infection

Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

Retrieved on: 
Wednesday, March 6, 2024

“People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.

Key Points: 
  • “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.
  • The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV /HBV coinfection.
  • Additionally, ALLIANCE participants treated with Biktarvy exhibited numerically higher levels of HBV viral suppression and seroconversion.
  • The primary outcome measure is viral suppression rates at Week 24, defined as HIV-1 RNA ˂50 copies/mL.

Bristol Myers Squibb Announces New Data from the Long-Term DAYBREAK Study Reinforcing Efficacy and Safety of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

Retrieved on: 
Thursday, February 29, 2024

Bristol Myers Squibb (NYSE: BMY) today announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).
  • In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098.
  • Three- and six-month confirmed disability progression was absent in 82.8% and 84.8% of participants in the trial respectively.
  • No new safety signals emerged; data from this long-term observational study of patients treated for up to 81.5 months were consistent with the established safety profile of Zeposia.

Groundbreaking! Phase II Data of LP-003 Unveiled by Longbio Pharma at AAAAI2024

Retrieved on: 
Sunday, February 25, 2024

The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference.

Key Points: 
  • The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference.
  • This Phase II study shows that 100mg LP-003 significantly improved nasal symptoms (TNSS score) of uncontrolled seasonal allergic rhinitis patients despite SoC treatment.
  • We are honored to unveiled the exciting Phase II results of LP-003, the first registrational clinical trial of anti-IgE antibody for AR conducted in China."
  • As Longbio Pharma charts its course forward, the successful Phase II study of LP-003 in allergic rhinitis represents a pivotal milestone in advancing the treatment landscape for allergic diseases.

Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

Retrieved on: 
Thursday, January 11, 2024

The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.

Key Points: 
  • The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.
  • In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application.
  • “Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet

Retrieved on: 
Wednesday, December 13, 2023

ANN ARBOR, Mich., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) announced today that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for NEXLETOL and NEXLIZET to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality has not been determined” has also been removed.

Key Points: 
  • These applications were accepted by the FDA which issued a PDUFA, or action, date of March 31, 2024.
  • The Company’s EMA applications also remain on track, with anticipated approval in the first half of 2024.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Dupixent® (dupilumab) Significantly Reduced COPD Exacerbations in Second Positive Phase 3 Trial, Accelerating FDA Submission and Confirming Potential to Become First Approved Biologic for This Serious Disease

Retrieved on: 
Monday, November 27, 2023

TARRYTOWN, N.Y. and PARIS, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) showed that Dupixent significantly reduced (34%) exacerbations, confirming positive results from the landmark Phase 3 BOREAS trial. The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks.

Key Points: 
  • “These results demonstrate the important role of type 2 inflammation in yet another chronic and debilitating disease, and the ability of Dupixent to address this inflammation.
  • Patients receiving Dupixent compared to placebo experienced:
    34% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0002), the primary endpoint.
  • BOREAS results showed:
    30% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0005), the primary endpoint.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.

Press Release: Dupixent® significantly reduced COPD exacerbations in second positive Phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease

Retrieved on: 
Monday, November 27, 2023

The second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) has shown that Dupixent significantly reduced (34%) exacerbations, confirming positive published results from the landmark Phase 3 BOREAS trial.

Key Points: 
  • The second Dupixent® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) has shown that Dupixent significantly reduced (34%) exacerbations, confirming positive published results from the landmark Phase 3 BOREAS trial.
  • These results were from an interim analysis and, given the overwhelming positive efficacy of the primary endpoint, will be considered the primary analysis of the trial.
  • Patients receiving Dupixent compared to placebo experienced:
    34% reduction in moderate or severe acute COPD exacerbations over 52 weeks (p=0.0002), the primary endpoint.
  • The safety and efficacy of Dupixent in COPD are currently under clinical investigation and have not been evaluated by any regulatory authority.