FDA update on brand drugs for October 22, 2009

[chantell.reagan]

Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant) by GlaxoSmithKline
Approval: prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females 10 through 25 years of age

•Link to FDA letter
•Link to prescribing information

Clinical differentiation (Cervarix vs. Gardasil):

•According to the American Cancer Society, of all cervical cancers related to HPV, 70% are caused by HPV types 16, 18. Both are covered by the Cervarix and Gardasil vaccines.
•In the US about 500,000 cases of pre-cancerous cell changes of the cervix, vagina, and vulva are diagnosed each year. Of these, over half are related to HPV 16 and 18
•Cevarix is about 89% effective in preventing precancerous lesions caused by HPV type 31, the 3rd most common cervical-cancer-causing strain, behind 16 and 18
•Low-grade changes in the cells of the cervix are caused by a variety of HPV types, including 6, 11, 16 and 18. Most go away without treatment, but some grow into warts, which are often removed. Additionally, 90% of anal and genital warts are caused by HPV types 6 and 11. Gardasil coveres these types, while Cervarix does not.

Prolastin-C (Alpha1-Proteinase Inhibitor [Human]) by Talecris Biotherapeutics
Approval: treatment of alpha1-antitrypsin (AAT) deficiency (Prolastin-C delivers twice the active protein per milliliter as Prolastin, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min)

•Link to news article 10/09

Twynsta (telmisartan/amlodipine) by Boehringer Ingelheim
Approval: treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals

•Link to BI press release 10/09
•Link to prescribing information

Votrient (pazopanib) by GlaxoSmithKline
Approval: an oral kinase inhibitor for the treatment of advanced renal cell carcinoma (RCC)

•Link to GSK press release 10/09
•Link to prescribing information

Expanded indications:

Colcrys (colchicine) by URL Pharma
Expanded indication: prevention of acute gout flares (previously approved in 8/09 for gout treatment and Mediterranean fever)

•Link to news article 10/09

Crestor (rosuvastatin) by AstraZeneca
Expanded indication: for use in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol

•Link to AZ press release 10/09
•Link to prescribing information

Elitek (rasburicase) IV injection by sanofi
Expanded indication: to treat complications from leukemia, lymphoma and other cancers in adults (FDA previously approved the drug for use in children in 2002)

•Link to sanofi press release 10/09
•Link to prescribing information

Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) by Merck
Expanded indication: for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11

•Link to Merck press release 10/09
•Link to prescribing information

Micardis (telmisartan) by Boehringer Ingelheim
Expanded indication: 80mg dose - reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events, who are unable to take angiotensin-converting enzyme (ACE) inhibitors

•Link to BI press release 10/09

Safety issues:
Dexferrum (iron dextran complex)
Safety issue: Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of Dexferrum injection, even in situations where the test dose was tolerated.

•Link to American Regent letter 9/09
•Link to FDA news

Sources:
American Cancer Society: Human Papilloma Virus, Cancer and HPV vaccines: FAQ
Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) prescribing information
US News and World Report 10/09
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER