This quarterly review on new drug applications contains data for applications approved for the first time during the fourth quarter of 2024, which includes New Molecular Entities (NMEs) and new biologics. A total of 31 applications were approved by the FDA during these three months. Based on submission classification, they can be divided as – Type 1: 30.3%, Type 3: 15.2%, Type 4: 6.1%, Type 5: 12.1% and BLA: 36.4%. Clearly, the focus was on developing new biological products.
The last quarter of 2024 approvals were divided into four different dosage forms. Following are the percentages of those dosage forms – 6.5% oral solution, 22.6% tablets, 61.3% injectable, and 9.7% capsules. All the BLAs were injectable products.
Hemophilia is a family of rare genetic blood diseases caused by a clotting factor deficiency (FVIII in hemophilia A, FIX in hemophilia B). Pfizer’s Hympavzi is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for the treatment of hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen.
Iterum Therapeutics received FDA approval for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (UTI) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options. An uncomplicated UTI is a bacterial infection of the bladder in women with no structural abnormalities of their urinary tract. A penem is a type of β-lactam with an unsaturated five-member heterocycle containing a sulfur atom in a pentacyclic ring fused to the β-lactam ring.
In November 2024, FDA had granted accelerated approval to Ziihera (zanidatamab-hrii) for previously treated unresectable or metastatic HER2-positive biliary tract cancer. FDA also approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera.
Soman or GD is an extremely toxic organophosphorous nerve agent, which inhibits enzyme cholinesterase. Pyridostigmine pretreatments counters the effect of nerve agent. The current PB treatment needs three doses per day. The newly approved product needs only one dose per day. This product offers potential for improved compliance and steady 24-hour release of the drug’s therapeutic benefit.
Beizray contains 20 mg/mL of docetaxel, an antineoplastic agent. Each vial contains drug solution in alcohol with citric acid for pH adjustment. The kit also contains a vial of IV solution stabilizer – a 25% albumin solution. The required amount of albumin solution is added to the 0.9% sodium chloride infusion bag. The required amount of drug solution is added to the infusion bag to get the drug concentration of 0.14 mg/mL to 0.31 mg/mL. The final infusion solution is stable for four hours at 25°C and up to 24 hours in the refrigerator.
Author Details
Neelam Sharma, Lavanya Kundurthy and Hemant N. Joshi, Ph.D., MBA, Tara Innovations LLC, [email protected]
Publication Details
This article appeared in Pharmaceutical Outsourcing:
Vol. 26, No.1Jan/Feb/Mar 2025Pages: 31-33