FDA Approves First Biosimilar of MS Drug Tysabri
Sandoz’s Tyruko, the first biosimilar to Biogen’s Tysabri, is expected to be available as soon as possible. Pricing has not yet been made available.
FDA Grants Priority Review to Xtandi for Earlier Treatment in Prostate Cancer
If approved, Xtandi would be the first hormonal therapy for non-metastatic patients with increasing PSA levels. The FDA has assigned an action date in the quarter of 2023.
FDA Sets Review Date for First-in-Class Therapy for MDS
The FDA set an action date of June 16, 2024, for imetelstat to treat transfusion-dependent anemia in myelodysplastic syndromes. Regulators said they plan to hold an advisory committee meeting as part of their review.
FDA Approves Abrysvo to Prevent RSV in Infants
Abrysvo is the first RSV vaccine approved to be given to pregnant women at 32 to 36 weeks to prevent infection in infants.
FDA Approves Ingrezza for Disorder Associated with Huntington’s Disease
In addition to tardive dyskinesia, Ingrezza now also treats chorea associated with Huntington’s disease, which is a movement disorder that effects coordination, gait, swallowing and speech.
FDA Approves Higher Dose Eylea
The higher dose of Eylea allows longer intervals between injections for patients with macular degeneration and diabetic retinopathy. It will have a list price of $2,625 per single-use vial.
FDA Approves Veopoz for Hereditary Immune Disease
Veopoz is the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The list price is $34,615.38 per single-use vial.
FDA Sets PDUFA Date for Full Approval of Tarpeyo
The FDA granted accelerated approval to Tarpeyo in December 2021 to treat patients with primary IgA nephropathy, a rare disease that attacks the kidneys. The action date for full approval is Dec. 20, 2023.
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 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.
What We’re Reading: Drug Prices May Lead to ACA Premium Increases; Dealing with Problem Doctors; Autism, Obesity and Other Co-Occurring Conditions
Fresenius Kabi Reaches Agreement with J&J over Stelara Biosimilar
Following similar agreements, the settlement allows Fresenius Kabi and Formycon to launch their ustekinumab biosimilar no later than April 15, 2025.
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 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.
What We’re Reading: Research Data Manipulation; Maternal Deaths from Lack of Abortion Care
Viatris Launches First Generic of Symbicort
Breyna is indicated for patients with asthma six years of age and as maintenance therapy for people with COPD.
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.
Stability and Purity Issues Lead to Recall of Tydemy
One of the two recalled lots of the birth control tested high for a known impurity.
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.
What We’re Reading: Medicaid Enrollment, Jailing People with Mental Illness and Ensuring Mental Health Parity
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.
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