September 29th 2023
The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.
Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
September 28th 2023
Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
September 27th 2023
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
FDA Grants Priority Review for Tibsovo sNDA for Myelodysplastic Syndromes
Tibsovo is currently approved in the United States as a monotherapy to treat adults with IDH1-mutant relapsed or refractory acute myeloid leukemia.
FDA Sets Review Date for Combination Antibiotic for Complicated UTIs
The FDA has granted priority review for cefepime-taniborbactam to treat patients with complicated urinary tract infections and set an action date of Feb. 22, 2024.
FDA Grants Accelerated Approval to Elrexfio for Multiple Myeloma
Elrexfio is a bispecific antibody to treat relapsed or refractory multiple myeloma. It will be available within the next few weeks and have a monthly list price of $41,500.
FDA Approves Long-Acting Botulinum Toxin for Cervical Dystonia
Daxxify is a long-acting botulinum toxin that will launch in 2024. It previously received FDA approval to treat frown lines.
FDA Approves Combination Tablet for Metastatic Prostate Cancer
The combination of niraparib and abiraterone in a single tablet — now with the name Akeega — will be available in mid-September and have a list price of $18,750 for a 30-day supply.
FDA Approves Talvey to Treat Blood Cancer
Talvey is a first-in-class bispecific antibody to treat adult patients with relapsed or refractory multiple myeloma. It will available in a few weeks and have a price of $45,000 per month.
FDA Issues Complete Response for Avasopasem for Severe Oral Mucositis
Avasopasem was under review to treat radiotherapy-induced severe oral mucositis in patients with head and neck cancer. The FDA has indicted that an additional trial would be needed to show safety and effectiveness of avasopasem.
FDA Sets PDUFA Date for Monthly MS Drug
The FDA has assigned a March 8, 2024, action date for GA Depot, a once-monthly injection to treat patients with relapsing forms of multiple sclerosis.
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.
Melinta Launches Rezzayo for Almost $2,000 a Vial
Rezzayo is a novel once-weekly antifungal to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain. It will have a wholesale acquisition cost of $1,950 per vial.
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.
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