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FDA Reviewers Flag "Discordant Results" for Rexulti-Sertraline PTSD Treatment Ahead of Advisory Committee Meeting

Drug Approval
  • FDA reviewers have identified "discordant results" in Otsuka Pharmaceutical's supplemental New Drug Application for brexpiprazole (Rexulti) combined with sertraline for PTSD treatment.
  • The fixed-dose study showed neither 2 mg nor 3 mg doses of Rexulti were superior to sertraline plus placebo, with reviewers calling it "clearly and convincingly a negative study."
  • This development represents another potential setback for PTSD treatment options, following the FDA's rejection of MDMA-assisted psychotherapy in 2024.
  • The FDA advisory committee will discuss these concerns on July 18, 2025, with approximately 13 million Americans currently struggling with PTSD and no new treatments approved in over 20 years.

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

NCT03033069CompletedPhase 2
Otsuka Pharmaceutical Development & Commercialization, Inc.
Posted 1/26/2017

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

NCT04174170CompletedPhase 3
Otsuka Pharmaceutical Development & Commercialization, Inc.
Posted 10/30/2019

Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

NCT04124614CompletedPhase 3
Otsuka Pharmaceutical Development & Commercialization, Inc.
Posted 10/17/2019

MIPLYFFA Shows 5-Year Sustained Efficacy in Rare NPC Disease Extension Study

Rare DiseaseDrug Approval
  • Zevra Therapeutics published long-term data showing MIPLYFFA (arimoclomol) sustained disease progression reduction for at least 5 years in Niemann-Pick disease type C patients.
  • The 48-month open-label extension study included more than 270 patients worldwide, with some receiving treatment for up to seven years.
  • Results demonstrated no new safety concerns and aligned with the pivotal Phase 2/3 trial that showed MIPLYFFA halted disease progression compared to placebo.
  • MIPLYFFA is approved by the FDA for use in combination with miglustat for treating neurological manifestations of NPC in patients 2 years and older.

FDA Reviewers Question Efficacy of Otsuka's Brexpiprazole-Zoloft Combination for PTSD Treatment

Drug Approval
  • FDA staff reviewers have raised significant efficacy concerns over Otsuka Pharma's brexpiprazole combination therapy for PTSD, citing inconsistent trial results and modest treatment effects that may lack clinical meaningfulness.
  • The combination drug failed to demonstrate substantial evidence of effectiveness when added to sertraline, with one late-stage study showing no statistically significant differences between combination therapy and sertraline monotherapy.
  • An FDA advisory panel meeting scheduled for Friday will provide recommendations on the approval of brexpiprazole combined with Viatris' Zoloft for treating adults with PTSD.
  • The FDA has delayed its original February 8 decision deadline and has not set a new action date for the drug application.

FDA Accepts Biosimilar Application for BAT2506, Proposed Golimumab Alternative

Monoclonal AntibodyDrug Approval
  • The FDA has accepted Bio-Thera Solutions' Biologics License Application for BAT2506, a proposed biosimilar to Simponi (golimumab), with a target review completion date of May 16, 2026.
  • The application seeks approval for all current Simponi indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, with interchangeability designation requested.
  • BAT2506 demonstrated similar efficacy, safety, and immunogenicity to reference golimumab in comprehensive Phase I and Phase III clinical studies.
  • Accord BioPharma will serve as the marketing authorization holder and commercialize the biosimilar in the United States if approved.

FDA Advisory Panel Votes Against GSK's Blenrep for Multiple Myeloma Over Eye Safety Concerns

Drug ApprovalOncology
  • FDA advisers voted that the risks of GSK's blood cancer drug Blenrep outweigh its benefits in treating multiple myeloma, citing serious eye-related side effects as a primary concern.
  • The drug causes ocular toxicity that represents "unique toxicity not seen with any currently available treatments for multiple myeloma," according to FDA staff reviewers.
  • FDA staff suggested that lower dosages of Blenrep could offer patients similar efficacy while reducing the risk of side effects, questioning the company's selected dose.
  • The FDA is expected to make its final approval decision by next week, though the agency does not have to follow the advisory panel's recommendation.

FDA Raises Eye Safety Concerns for GSK's Blenrep Ahead of Advisory Committee Review

Drug Approval
  • The FDA has identified significant ocular toxicity concerns with GSK's Blenrep (belantamab mafodotin) ahead of a July 17 advisory committee meeting to review the drug's reintroduction to the U.S. market.
  • Clinical trials DREAMM-7 and DREAMM-8 showed that 92-93% of patients experienced keratopathy and visual acuity events, with 77-78% experiencing serious grade 3-4 events.
  • GSK withdrew Blenrep from the U.S. market in 2022 after confirmatory trial shortcomings, despite initial FDA approval in 2020 for multiple myeloma treatment.
  • The company's stock fell 1.19% following the FDA briefing document release, as eye safety concerns represent a unique toxicity profile among multiple myeloma therapies.

FDA Approves Kirsty as First Interchangeable Rapid-Acting Insulin Aspart Biosimilar

Drug Approval
  • The FDA has approved Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar to NovoLog, expanding treatment options for diabetes patients.
  • Kirsty can be substituted for NovoLog at the pharmacy without a new prescription, potentially streamlining access and driving competition in the insulin market.
  • The approval addresses critical access issues for over 8.4 million Americans dependent on insulin therapy, with studies showing 1 in 5 adults under 65 ration insulin due to cost.
  • Biocon Biologics' second interchangeable insulin biosimilar builds on their diabetes portfolio, following Semglee as the first approved interchangeable biosimilar insulin.

Iovance Biotherapeutics Names Corleen Roche as CFO During Commercial Launch of First FDA-Approved TIL Therapy

Drug Approval
  • Iovance Biotherapeutics appointed Corleen Roche as Chief Financial Officer effective August 6, 2025, during the commercial launch of its groundbreaking TIL therapy.
  • Roche brings 30 years of biotech experience including CFO roles at CG Oncology, Immunome, and Biogen, with expertise in multiple product launches.
  • The appointment comes as Iovance commercializes Amtagvi, the first FDA-approved T cell therapy for solid tumors, marking a significant milestone in cancer treatment.
  • Roche will focus on revenue growth and pipeline investments as the company advances its tumor infiltrating lymphocyte platform across multiple solid tumor indications.

Zydus Lifesciences Receives FDA Approval for Generic Celecoxib Capsules in Multiple Strengths

Drug Approval
  • Zydus Lifesciences Limited has received final FDA approval for Celecoxib Capsules in four strengths (50 mg, 100 mg, 200 mg, and 400 mg) as a generic version of Celebrex.
  • The NSAID medication is indicated for treating pain and inflammation from arthritis, ankylosing spondylitis, menstrual pain, and juvenile rheumatoid arthritis in children aged 2 years and older.
  • The approved generic targets a significant market opportunity, with annual sales of USD 122.6 million in the United States according to IQVIA data.
  • This approval brings Zydus's total FDA approvals to 428, with capsules to be manufactured at their Ahmedabad facility.

Follicular Lymphoma Market Poised for 6% CAGR Growth Through 2034 as Novel Therapies Advance

CAR-TDrug Approval
  • The follicular lymphoma market is projected to grow at a 6% CAGR during 2025-2034, driven by increased disease awareness and rising number of clinical trials focused on this slow-growing B-cell malignancy.
  • Recent regulatory approvals include Japan's approval of EPKINLY (epcoritamab) as the first subcutaneous T-cell engaging bispecific antibody for relapsed/refractory follicular lymphoma, and FDA approval of tafasitamab-cxix combination therapy.
  • The market was valued at approximately $1.082 billion in 2024, with the United States representing the largest market and approximately 35,000 new cases diagnosed across seven major markets.
  • Over 45 companies are developing 50+ therapies in the pipeline, including innovative approaches like CAR-T cell treatments, bispecific antibodies, and targeted therapies from companies such as Regeneron, AstraZeneca, and Bristol Myers Squibb.

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

NCT04680052Active, Not RecruitingPhase 3
Incyte Corporation
Posted 4/15/2021

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