SPOTLIGHT -
FDA Approves Subcutaneous Vyvgart for Myasthenia Gravis
Vyvgart Hytrulo’s under-the-skin administration means it can be given in 30 to 90 seconds, compared with one hour for the intravenous product. It will be priced at parity to Vyvgart, which has a net price of $225,000 annually.
Geron Submits NDA for First-in-Class Therapy for MDS
Imetelstat targets telomerase to inhibit uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies.
FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease
Lodoco targets the inflammation that is an underlying cause of atherosclerotic cardiovascular disease. It will be available in the second half of 2023.
FDA Issues Complete Response for Drug for Rare Fungal Infections
The FDA is requesting additional data and analysis for olorofim. F2G plans to resubmit revised NDA with complete data set from phase 2 study.
KFF Survey: Patients Concerned about Drug, Healthcare Costs
About a quarter of those surveyed said their insurance didn’t cover a needed prescription drug or charged a very high copay.
FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma
Columvi will cost about $350,000 for a fixed duration therapy with 12 treatments over eight and a half months.
Labeling Mix up Leads to Recall of Dronabinol and Ziprasidone
Ziprasidone is used to treat patients with schizophrenia and bipolar disorder. Taking dronabinol instead may lead to worsening of mental illness symptoms.
FDA Approves Linzess to Treat Children with Constipation
Linzess is first FDA-approved prescription therapy for functional constipation in children 6 to 17 years of age.
FDA Approves Novel Cyclosporine for Dry Eye Disease
Vevye (previously CyclASol) is a water-free, preservative-free solution, which allows for improved bioavailability and better efficacy on the target tissue.
FDA to Review sBLA for Jemperli for Earlier Treatment of Endometrial Cancer
The FDA has assigned an action date of Sept. 23, 2023. If approved, this would be the first frontline treatment advancement in decades for patients with advanced or recurrent endometrial cancer.
FDA Approves Prevymis for CMV Prevention in Kidney Transplant Patients
Prevymis was approved to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant in 2017.
Amazon to Offer Pharma Company Coupons on Branded Drugs
The new feature automatically applies manufacturer-sponsored coupons directly to an eligible patient’s order. So far, just a few pharma companies have made their coupons available through Amazon.
FDA Rejects NDA for Extended-Release Jakafi
Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.
Impurities Lead to Recall of 10 Lots of Dabigatran
The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.
FDA Wants More Information about AbbVie’s Parkinson’s Therapy
In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
FDA Extends Evkeeza Indication to Include Young Children
Evkeeza treats a rare form of high cholesterol. It is now approved for patients as young of 5 years of age.
FDA Expands Illuccix Label to Identify Patients for Treatment with Pluvicto
Illuccix is for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
HHS Names 27 Drugs Subject to Medicare Inflation Rebates
Medicare Part B beneficiaries are expected to save between $2 and $390 per average dose starting April 1, 2023.
Bacterial Contamination Leads to Recall of Antifungal Drug
Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.
CMS Grants Aponvie Pass Through Status
Aponvie is the first intravenous version of aprepitant adults to prevent postoperative nausea and vomiting.
CMS Grants Pass-through Reimbursement for Iheezo
Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.
FDA Approves Novel Nasal Spray for Migraine
Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved for patients with acute migraine.
VA Adds ALS Therapy Radicava ORS to National Formulary
Radicava ORS will be available with a national prior authorization process in place.
FDA Accepts sNDA for Jardiance in Children 10 to 17 with Diabetes
If approved, Jardiance would be the first SGLT2 inhibitor indicated for this population. A decision is expected in the second quarter of 2023.
FDA Assigns Target Date for Voxzogo in Young Children with Dwarfism
Voxzogo is already available to treat patients older than five years with a genetic cause of dwarfism. The FDA has set a PDUFA of Oct. 21, 2023, for children younger than 5.
FDA Sets Action Date for Nerve Disorder Drug
With a Prescription Drug User Fee Act action date of Dec. 22, 2023, eplontersen is an antisense medicine to treat patients living with hereditary transthyretin-mediated amyloid polyneuropathy, which results in nerve damage.
FDA Extends Review of Hemophilia A Gene Therapy
The agency has set a new PDUFA target action date of June 30, 2023, for Roctavian. If approved, it would be the first one-time gene therapy for hemophilia. A.
Patients Oppose Prior Authorization Policies, Finds New Poll
The majority of consumers surveyed by Let My Doctor Decide support reforms to improve access and affordability.
FDA Grants Priority Review to Leqembi for Traditional Approval
The FDA plans to hold an advisory committee meeting to discuss the Alzheimer’s therapy. The agency has assigned Prescription Drug User Fee Act target action of July 6, 2023.