SPOTLIGHT -
FDA Approves Izervay to Treat Geographic Atrophy
Izervay, which is expected to be available within the two to four weeks, will have a list price of $2,100 per vial.
FDA Approves Oral Treatment for Postpartum Depression
Zurzuvae is a rapid-acting neuroactive steroid that is expected to be available in the fourth quarter of 2023.
FDA Approves Lonsurf Combination for Metastatic Colorectal Cancer
Trial results showed that the combination of Lonsurf and bevacizumab provided improvements in overall survival.
FDA Approves Jemperli as Frontline Treatment for Advanced Endometrial Cancer
Jemperli is the first immuno-oncology treatment approved in the frontline setting for patients with advanced or recurrent endometrial cancer.
FDA Rejects BLA for Therapy to Treat Rare Skin Cancer
The FDA is requiring Citius Pharmaceuticals to do enhanced product testing for Lymphir (formerly I/Ontak) to treat patients with cutaneous T-cell lymphoma.
FDA Approves Second Over the Counter Naloxone Nasal Spray
Harm Reduction Therapeutics will supply at least 200,000 free doses of RiVive to communities that need it most.
FDA Approves Xdemvy for Eye Infection Caused by Mites
Xdemvy is the first treatment that directly targets the mites involved in the Demodex blepharitis. It is expected to be available by the end of August 2023 and will have a list price of $1,850 per prescription.
FDA Accepts sNDA for Ofev in Children with Rare Lung Disease
If approved, Ofev would be the first approved treatment for children and adolescents with fibrosing interstitial lung disease. A decision is expected in the fourth quarter of this year.
FDA Approves First Drug for Skin Infection from Pox Virus
Ycanth, a topical treatment for molluscum contagiosum, will be available in September. Pricing information has not yet been released.
FDA Approves Postexposure Anthrax Vaccine
Emergent BioSolutions has been providing the Cyfendus vaccine to the U.S. Department of Health and Human Services since 2019, under a pre-emergency use authorization status.
FDA Approves Novel Therapy for Newly Diagnosed AML
Vanflyta is the first FLT3 inhibitor approved to treat patients with newly diagnosed acute myeloid leukemia across three phases of treatment. It has a list price of $199,290 annually.
FDA Clears First Monoclonal Antibody for RSV in Infants
Beyfortus will be available ahead of the upcoming 2023-2024 RSV season. A price has not yet been set.
FDA Decision on Donanemab for Alzheimer’s Expected by End of Year
Donanemab slowed cognitive decline by about 35% for patients at the earliest stages of Alzheimer’s disease.
FDA Approves First Nonprescription Oral Contraceptive
Opill will be available in stores and online in the first quarter of 2024.
Takeda Pulls Application for Dengue Vaccine
Takeda indicated that it could not address issues related to aspects of data collection within the current BLA review cycle.
FDA Approves Leqvio for Earlier Use in Heart Disease
The label for Leqvio has also been updated to remove four adverse events based on recent safety data.
CMS Expands Leqembi Coverage After FDA’s Full Approval
Medicare will cover Alzheimer’s drugs with full approval, including Leqembi — if the physician and patient participate in a real-world registry trial to gather additional data.
FDA Sets Action Date for Zolbetuximab for Stomach Cancers
Zolbetuximab is a first-in-class therapy for advanced gastric and gastroesophageal cancers. The target action date is Jan. 12, 2024.
FDA Rejects Amneal’s Application for Novel Parkinson’s Therapy
The FDA is asking for more pharmacokinetic data on carbidopa, one of the drugs within IPX203. The therapy is an extended-release, oral formulation of carbidopa/levodopa.
FDA Approves $2.9 Million Gene Therapy for Hemophilia A
BioMarin is offering an outcomes-based warranty that will reimburse payers up to 100% of the cost if a patient does not respond to Roctavian.
New Pediatric Growth Hormone Therapy Costs $8,300 Monthly
Longer-acting growth hormone reduces frequency of injections. It will be available in August.
FDA Approves First Cellular Therapy for Type 1 Diabetes
In two small studies, patients were able to be free from insulin injections for a year or more.
FDA Rejects Higher Dose of Eylea
At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.
FDA Approves Rystiggo for Generalized Myasthenia Gravis
It will be commercially available in the third quarter of 2023 and have a list price of $6,050 per vial.
FDA Sets Action Date for Hemophilia B Gene Therapy
Pfizer’s biologics license application (BLA) for the gene therapy fidanacogene elaparvovec has been assigned a PDUFA date in the second quarter of 2024.
FDA Converts Blincyto to Full Approval for Minimal Residual Disease in B-Cell ALL
Blincyto is immuno-oncology therapy that targets CD19 surface antigens on B cells to treat patients with acute lymphoblastic leukemia. Its current wholesale acquisition cost price is $4,900.15 per vial.
FDA Approves Pfizer’s Alopecia Drug
Now with the name Litfulo, ritlecitinib is the first oral treatment for adolescents with alopecia. It has an annual list price of $49,000.
First Gene Therapy for Duchenne Priced at $3.2 Million
Elevidys is a one-time therapy that delivers to muscle a gene that codes for a shortened, functional form of dystrophin, which is mutated in Duchenne muscular dystrophy.
FDA Rejects NDA for Fatty Liver Disease Therapy
The company plans to discontinue further research of obeticholic acid to treat nonalcoholic steatohepatitis (NASH) after the FDA asked for long-term outcomes data.
FDA Issues CRL for Treatment for Rare Retinal Cancer
Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.