SPOTLIGHT -
FDA Grants Accelerated Approval to Filspari for Rare Kidney Disease
Filspari will be available for a wholesale acquisition cost of $9,900 for a 30-day supply, and administrated through a REMS program because of the risk of liver abnormalities.
FDA Extends Review of Fezolinetant for Menopause Symptoms
The review has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is May 22, 2023.
Approves Enzyme Replacement Therapy for Rare Disease
Lamzeda has been approved to treat patients with alpha-mannosidosis, a rare genetic condition. It will be available in the first half of this year.
FDA Grants Priority Review to Prevymis to Prevent CMV After Kidney Transplants
The Prescription Drug User Fee Act action date is June 5, 2023. Prevymis is already approved to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant.
FDA Grants Priority Review to AMD Therapy
Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.
FDA Grants Priority Review Talzenna/Xtandi Combo in Prostate Cancer
Phase 3 data showed that the combination resulted in a 37% reduction in risk of disease progression or death in men with advanced prostate cancer.
Ferring Launches First Microbiome Therapy to Prevent C. Diff Infection
No list price was provided for Rebyota but Ferring is offering copay and patient assistance programs.
FDA Refuses NDA for Cutaneous T-Cell Lymphoma
The FDA indicated that Soligenix’s application for HyBryte, a novel photodynamic therapy, was incomplete.
FDA Grants Priority Review for Linzess in Children, Adolescents
If approved, Linzess would be the first and only FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age. The PDUFA date is June 14th, 2023.
Blackley on the Impact of State PBM Regulations
Chris Blackley, co-founder and chief executive officer of Prescryptive Health, discusses the laws that states that are implementing to restrict PBM practices and the impact on patients and employers.
FDA Expands Cibinqo Label for Atopic Dermatitis in Adolescents
Cibinqo is an oral, once-daily JAK1 inhibitor now approved for those 12 years of age and older.
FDA Grants Full Approval to Jemperli for Endometrial Cancer
Conversion from accelerated to regular approval was based on long-term outcomes from a phase 1 trial, which demonstrated an overall response rate of 45.4%.
FDA Sets PDUFA Date for Dry Eye Disease Drug
If approved, reproxalap would be the first inhibitor of RASP to treat patients with dry eye disease. The FDA PDUFA date is Nov. 23, 2023.
FDA Accepts NDA for Zuranolone for Depression
Zuranolone is a rapid-acting neuroactive steroid that can take effect in 14 days to treat patients with major depressive disorder and postpartum depression. The FDA has assigned a PDUFA action date of Aug. 5, 2023.
FDA Approves Trodelvy for HR+/HER2- Breast Cancer
Trodelvy has been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.
FDA Approves Tezspire in Pre-Filled Pen
Tezspire is a biologic that specifically targets the inflammation associated with asthma.
Subpotency Leads to Recall of 27 Lots of Tirosint-SOL
IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.
Daiichi Sankyo Makes Available New Dosing Regimen for Turalio
Dosing has been lowered to reduce the risk of liver damage in patients taking Turalio, which is approved to treat patients with a rare tumor that affects the joints.
Mark Cuban’s Pharmacy Teams up With Cancer Health App
The collaboration between Cost Plus Drugs and OncoPower provides access to generic medications for patients with cancer integrated with OncoPower’s Pill Reminder tool.
FDA Approves Orserdu to Treat Metastatic Breast Cancer
Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.
FDA Approves Lilly’s BTK Inhibitor for Rare Blood Cancer
Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.
FDA Approves Keytruda for Lung Cancer After Surgery
This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.
FDA Removes Evusheld’s EUA for COVID-19
AstraZeneca is developing a next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19, which it plans to make available in the second half of 2023.
Analysis: Payers Restrict Medications for Autoimmune Diseases
Three out of four health plans scored a “C” or an “F” because of utilization management restrictions they place on medication for autoimmune conditions.
FDA to Hold Advisory Committee Meeting for ALS Drug
The Peripheral and Central Nervous System Drugs Advisory Committee meeting is scheduled for March 22, 2023, to review Biogen’s tofersen.
FDA Approves New Drug for Type 2 Diabetes
Once-daily, oral SGLT2 inhibitor Brenzavvy has been shown to reduce blood sugar and improve glycemic control.
FDA Accepts Jardiance sNDA for CKD Indication
A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.
FDA Issues Complete Response for Lilly Alzheimer’s Drug
Lilly expects topline results from the confirmatory phase 3 trial in the second quarter of 2023 and plans to submit for full approval.
FDA Approves Brukinsa for Chronic Lymphocytic Leukemia
This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.
FDA Approves Tukysa for HER2 Positive Colorectal Cancer
Tukysa with trastuzumab is indicated for second-line treatment of HER2-positive metastatic colorectal cancer, the first such therapy for this cancer.
