FDA issues 2005 approvals for drugs, biologic products
FDA issues 2005 approvals for drugs, biologic products
CDER’s approvals for NMEs decrease from 2004
The FDA recently announced its 2005 approvals for new drug applications (NDAs) and biologic license applications (BLAs).
The Center for Drug Evaluation and Research (CDER), the FDA’s organization for setting and ensuring the standards for the safety and effectiveness of drugs and certain therapeutic biologic products, approved 78 new drug applications (NDAs) and two biologic license applications (BLAs) in 2005. Of these 80 approvals, 20 were for New Molecular Entities (NMEs), products that have not previously been marketed. While this represents a relatively low number of NME approvals historically, the FDA says, 15 of these approvals were designated for priority reviews (down from 21 in 2004). The five approved under standard review was 10 fewer than was approved under standard review in 2004. CDER also approved 13 orphan-designated products for the treatment of rare diseases.
The median total approval time for priority review remained the same as 2004 — six months. The median total approval time for standard review decreased slightly from 24.7 months in 2004 to 23 months in 2005.
Significant CDER approvals in calendar year 2005 include:
- Entecavir (Baraclude) for the treatment of chronic hepatitis B virus infection.
- Mecasermin (Increlex) and mecasermin rinfabate (IPLEX) for the long-term treatment of growth failure in children with severe primary growth-factor deficiency.
- Tipranivir (Aptivus), in combination with ritonavir, for the antiretroviral treatment of HIV-1-infected adult patients with evidence of viral replication. These patients already had used many HIV medicines, and had a type of virus resistant to currently available HIV therapy. This new combination therapy provides a new treatment option for patients with limited options.
- Abatacept (Orencia) for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
- Sorafenib (Nexavar) for the treatment of patients with advanced renal cell carcinoma.
In addition, CDER approved 452 generic medications. Generic products approved in 2005 include 13 treatments for HIV/AIDS that will be available for purchase abroad as part of the President’s Emergency Plan for AIDS Relief.
CBER approves 18 BLAs in 2005
The FDA’s Center for Biologics Evaluation and Research (CBER) approved 18 BLAs in 2005. Six of the 2005 approvals were for vaccines, a category of products that is important because of the potential risks of pandemic influenza and bioterrorism.
CBER oversees the safety and effectiveness of biological products, including vaccines, blood and blood components, human tissues, certain medical devices, and novel products such as cell-, gene-, and tissue-based therapies. CBER’s major product approvals in 2005 include:
- Fluarix, GlaxoSmithKline’s (GSK’s) influenza vaccine for immunization of adults ages 18 and older against influenza caused by virus types A and B. Fluarix, which was approved in just over three months, was the first vaccine to receive the FDA’s accelerated approval.
- Two Vaccinia Immune Globulin Intravenous (VIGIV) products to treat certain rare complications of smallpox vaccination. Both products were granted priority review.
- Procleix WNV Assay, the first test to screen blood, tissue, cell, and organ donors for West Nile virus. The test will help protect patients who receive blood and other donated products against West Nile infection. In the past, about 30 patients are believed to have acquired the virus from a blood transfusion, and nine of them died.
- Two new combination vaccines to prevent whooping cough: Boostrix (GSK) for adolescents ages 10-18, and Adacel for ages 11-64.
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