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Health Canada Approves First-of-Its-Kind Antibody-Drug Conjugate for Multiple Myeloma Treatment

Drug ApprovalOncologyTargeted Therapy
  • Health Canada has approved Blenrep, a first-of-its-kind antibody-drug conjugate for multiple myeloma treatment, representing a significant advancement for patients with this incurable blood cancer.
  • The drug features a unique dual mechanism that combines targeted antibody binding with attached cytotoxic payload to specifically kill myeloma cells in the bone marrow.
  • Blenrep is administered to patients who have undergone stem cell transplant and one prior line of therapy, offering an "off-the-shelf" treatment option that requires no special preparation.
  • The approval adds another therapeutic option to the treatment chain for multiple myeloma patients, potentially extending disease control for years and offering hope for significantly longer survival.

FDA Accepts Kura Oncology's NDA for Ziftomenib in NPM1-Mutant AML with Priority Review

Drug Approval
  • The FDA has accepted Kura Oncology's new drug application for ziftomenib, an oral menin inhibitor for treating relapsed or refractory acute myeloid leukemia with NPM1 mutations.
  • The agency granted priority review with a decision expected by November 30, 2025, potentially making ziftomenib the first approved menin inhibitor for this indication.
  • The NDA was based on positive results from the phase II KOMET-001 study, which met its primary endpoint of complete remission with statistical significance.
  • Kura Oncology's stock surged 15.5% following the FDA acceptance, reflecting investor confidence in the drug's approval prospects.

FDA Grants Phathom Pharmaceuticals 10-Year Market Exclusivity for VOQUEZNA Through 2032

Drug Approval
  • The FDA has approved Phathom Pharmaceuticals' Citizen Petition and will correct the Orange Book to recognize 10 years of New Chemical Entity exclusivity for VOQUEZNA (vonoprazan) tablets, extending through May 3, 2032.
  • VOQUEZNA is a first-in-class potassium-competitive acid blocker (PCAB) currently marketed for treating heartburn associated with Non-Erosive GERD, healing and maintenance of Erosive GERD, and H. pylori infection in adults.
  • The regulatory exclusivity provides Phathom with significant market protection for their gastrointestinal disease treatment portfolio, including VOQUEZNA TRIPLE PAK and DUAL PAK formulations.
  • This FDA decision strengthens Phathom's competitive position in the acid-blocking therapy market and supports their commercialization strategy for vonoprazan-based treatments.

Aytu BioPharma Secures Exclusive Rights to First-in-Class Antidepressant EXXUA for $22B US Market

Drug Approval
  • Aytu BioPharma has secured exclusive US commercialization rights for EXXUA (gepirone), the first FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder in adults.
  • EXXUA demonstrated significant improvement in depression symptoms across clinical trials involving over 5,000 patients, with sexual side effects comparable to placebo rather than typical antidepressants.
  • The company plans to launch EXXUA in Q4 2025 to compete in the over $22 billion US prescription MDD market, targeting 21 million affected Americans.
  • The transaction was financed by healthcare-focused institutional investors including Nantahala Capital Management and Stonepine Capital Management.

Aytu BioPharma Raises $16.6M to Launch First-in-Class Depression Treatment EXXUA

Drug Approval
  • Aytu BioPharma completed an upsized public offering raising $16.6 million to commercialize EXXUA, the first FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder.
  • EXXUA represents a breakthrough in depression treatment as it demonstrates comparable sexual side effects to placebo, addressing a major limitation of current antidepressants.
  • The company plans to launch EXXUA in Q4 2025 to compete in the $22 billion U.S. prescription major depressive disorder market.
  • Clinical trials involving over 5,000 patients showed significant improvement in depression symptoms with EXXUA's novel mechanism of action.

Nemluvio Shows Sustained Long-Term Efficacy in Atopic Dermatitis with Two-Year Extension Data

Monoclonal AntibodyDrug Approval
  • New two-year data from the ARCADIA long-term extension study demonstrate that Nemluvio (nemolizumab) maintains sustained and increased improvements in itch, skin lesions, sleep, and quality of life in patients with moderate-to-severe atopic dermatitis.
  • At week 104, more than 85% of evaluable patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI), with approximately 85% achieving at least four-point improvement in itch scores.
  • The study reinforces Nemluvio's rapid onset of action at week 4 and demonstrates a consistent safety profile with no new safety signals identified during prolonged treatment up to two years.

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03989349CompletedPhase 3
Galderma R&D
Posted 6/30/2019

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

NCT04202679CompletedPhase 3
Sanofi
Posted 1/16/2020

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04204616Active, Not RecruitingPhase 3
Galderma R&D
Posted 1/11/2021

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03985943CompletedPhase 3
Galderma R&D
Posted 6/27/2019

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

NCT04183335CompletedPhase 3
Sanofi
Posted 12/12/2019

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

NCT03989206Active, Not RecruitingPhase 3
Galderma R&D
Posted 12/30/2019

Foldax Receives World's First Approval for Polymer Heart Valve in India

Drug Approval
  • Foldax's TRIA Mitral Valve becomes the first commercial polymer heart valve approved anywhere in the world, receiving regulatory clearance from India's Central Drugs Standard Control Organization.
  • The valve is made from proprietary LifePolymer material engineered to be calcium-resistant and biocompatible, addressing durability limitations of traditional tissue valves and anticoagulation requirements of mechanical valves.
  • Clinical research demonstrates favorable safety, stable hemodynamics, and meaningful improvements in patient quality of life, with particular benefits for younger patients and women of childbearing age.
  • The approval marks a potential paradigm shift in heart valve therapy, with Dolphin Life Science India LLP set to manufacture the device locally.

Adolescent Obesity Medication Prescriptions Surge 301% Despite Persistent Access Barriers

Drug Approval
  • Obesity medication prescriptions among US adolescents aged 12-17 years increased by 301.7% between 2020 and 2023, driven primarily by FDA approvals of semaglutide and phentermine-topiramate for pediatric use.
  • Despite the dramatic increase, only 0.5% of adolescents with obesity received medication prescriptions in 2023, highlighting significant treatment gaps in this population.
  • Substantial disparities emerged in prescribing patterns, with Black adolescents receiving medications at lower rates than White adolescents despite having higher rates of severe obesity.
  • Access barriers including high out-of-pocket costs, insurance coverage limitations, and provider knowledge gaps continue to limit widespread adoption of evidence-based obesity treatments.

Kennedy Pledges Accelerated FDA Approvals for Rare Disease Therapies to Maintain US Biotech Leadership

Drug ApprovalRare Disease
  • Health Secretary Robert F. Kennedy Jr. announced plans to fast-track FDA approvals for rare disease treatments and remove regulatory obstacles during a meeting focused on cell and gene therapies.
  • FDA's new biologics chief Vinay Prasad committed to rapidly making therapies available at the first sign of biomedical success, addressing industry concerns about regulatory barriers.
  • Panel experts warned that slower US approval processes risk losing biotechnology leadership to countries like China, potentially forcing companies to relocate trials overseas.
  • Biotech stocks responded positively, with therapy developers seeing gains of 1-8% following the regulatory reform announcements.

Servier India Launches First-in-Class IDH1-Targeted Therapy Ivosidenib for Rare Blood and Bile Duct Cancers

Targeted TherapyDrug ApprovalOncologyRare DiseasePrecision Medicine
  • Servier India received CDSCO approval on May 14, 2025, to launch Ivosidenib (Tibsovo®), the first oral targeted therapy for IDH1-mutated acute myeloid leukemia and cholangiocarcinoma in India.
  • The therapy addresses a critical unmet medical need, as only 30-40% of AML patients in India receive adequate treatment and IDH1 mutations occur in approximately 7-14% of Indian AML patients.
  • Ivosidenib has already gained regulatory approval in over 42 countries, including FDA approval in 2019 and EMA approval in 2023 for specific patient populations.
  • The company is prioritizing accessibility and affordability through collaborations with healthcare providers, patient advocacy groups, and policymakers to ensure broader patient access across India.

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