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FDA Accepts sBLA for Interchangeability Designation for Hadlima, a Humira Biosimilar

The US Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application (sBLA) for the interchangeability designation or Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira(adalimumab).

Once a biosimilar product is designated as an interchangeable biosimilar by the FDA, it can be used to replace the reference product by someone other than the prescriber without the need to consult the prescriber.

The sBLA, which was submitted to the FDA by Samsung Bioepis in August 2023, was based on clinical data from the phase 4 study assessing the pharmacokinetic similarity between two treatment groups: patients with moderate-to-severe plaque psoriasis who switched multiple times between high-concentration formulations of Humira and Hadlima versus patients receiving Humira continuously. Hadlima is developed, manufactured and supplied by Samsung Bioepis, and marketed by Organon.

Hadlima was first approved by the FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022. Hadlima was introduced into the US commercial market on July 1, 2023.

ACAAI News: 72% of AD Patients Report Poor Mental Health for 1 to 10 Days in the Past Month

Patients with atopic dermatitis (AD) are more likely to report poor mental health than their counterparts without the inflammatory skin condition, new research shows.

The study, which was presented at the 2023 American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting in Anaheim, CA, showed that 72% of people with AD, poor mental health symptoms for 1 to 10 days within the past month, while 17% reported more than 11 days.

“People who don’t suffer with AD don’t understand how debilitating it can be,” says Allison Loiselle, PhD, lead author on the study for the National Eczema Association, in a news release. “In addition to the terrible itching and dry, cracked skin, there are often sleep disruptions, and broader impacts on quality of life and overall well-being. Depression and anxiety are among the symptoms of those who deal with AD, and the chronic, unpredictable nature of this condition.”

Of 954 people who completed the survey, 23% were seeing an allergist as part of their AD care team. For 124 (96 adults and 28 caregivers), their allergist was their/their child’s primary eczema provider. Most patients reported current AD severity as mild (36%) and 72% reported poor mental health symptoms for 1 to 10 days within the past month. And, 17% reported more than 11 days. One third (35%) said they had never brought up mental health with their allergist, and 57% said they had never been asked about it. In all, 45% of respondents said their allergist had referred them to mental health services or resources.

Ventyx Biosciences Halts Trial for Experimental Psoriasis Drug

Ventyx Biosciences has announced it is halting development of an experimental psoriasis drug due to missed internal targets required for it to advance beyond phase 2, according to the company.

The drug, VTX958, had shown acceptable safety and efficacy, and had achieved with its 225 mg BID and 300 mg BID doses a statistically significant improvement in the primary endpoint and all key secondary endpoints.

Phase 2 of the SERENITY study was a 16-week randomized, double-blind, placebo-controlled, dose-ranging trial evaluating the safety and efficacy of four oral doses of VTX958 (50 mg BID, 300 mg BID, 225 mg BID, and 300 mg BID) in patients with moderate-to-severe plaque psoriasis. The primary study endpoint was the proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) at Week 16.

The ongoing phase 2 trial in Crohn’s disease will continue to enroll, according to the company.

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