FDA Pipeline preview, December 2008 (denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, RTA 402)
Recent FDA action (through December 2008) related to denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, and RTA 402
Complete responses
• Denileukin diftitox (Ontak, Eisai) for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells did not test positive for the CD25 component of the interleukin-2 receptor
•Controlled-release hydrocodone plus acetaminophen (Abbott) for the relief of pain over 12 hours
Priority review
•Cetuximab (Erbitux, ImClone/Bristol-Myers Squibb) for use in combination with platinum-based chemotherapy for the first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck
Orphan drug designations
•HQK-1001 (HemaQuest) for the treatment of sickle cell anemia and beta thalassemia
•ALD-101 (Aldagen) to decrease time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation
•NTX-010 (Neotropix) for the treatment of neuroendocrine tumors
•RTA 402 (Reata) for the treatment of pancreatic cancer
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
Read More
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More
