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• Agalsidase (Replagal) has received fast-track status from the FDA for treating Fabry disease.¹⁴ It is an enzyme replacement therapy.
• Exenatide LAR (Bydureon), the once-weekly version of exenatide (Byetta), is in final discussions at the FDA. The FDA has asked for additional information related to the product label, risk mitigation, and manufacturing, which the manufacturer is addressing.¹⁵
• Insulin powder for inhalation, ultra-rapid-acting (Afrezza), has been reviewed by the FDA, and the agency has requested additional information related to safety and labeling.¹⁶
• A combination therapy of saxagliptin/metformin has been submitted to the FDA as a once-daily treatment of Type 2 diabetes mellitus as an adjunct to diet in adults who cannot adequately control their diabetes on metformin monotherapy, or in treatment-naïve patients.¹⁷
• Vilanterol/fluticasone is a combination of the inhaled corticosteroid fluticasone and the long-acting beta-agonist (LABA) vilanterol, which is currently in Phase 3 clinical trials for treating asthma.¹⁸ The trial will compare the combination’s efficacy and safety to fluticasone/salmeterol (Advair). TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Cadence pharmaceuticals receives complete response letter from FDA for intravenous acetaminophen NDA. Cadence Pharmaceuticals website. Available at: http://cadx.client.shareholder.com/releasedetail.cfm?ReleaseID=444303. Accessed March 23, 2010.
2. Cadence pharmaceuticals reports fourth quarter and full year 2009 financial results. Cadence Pharmaceuticals website. Available at: http://files.shareholder.com/downloads/CADX/874963043x0x359109/1cf00f72-0872-4d4e-b27d-bde1c03d625a/CADX_News_2010_3_15_General_Releases.pdf. Accessed March 23, 2010.
3. Bayer lung infection drug gets orphan status. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/11/business-energy-us-bayer-healthcare-orphan-drug_7427368.html. Accessed March 23, 2010.
4. FDA grants orphan status for Bayer’s ciprofloxacin for cystic fibrosis. The Pharma Letter website. Available at: http://www.thepharmaletter.com/file/4e4fb33313eddf122cdb730e3ea71840/fda-grants-orphan-status-for-bayers-ciprofloxacin-for-cystic-fibrosis.html. Accessed March 23, 2010.
5. Burgess S. FDA approves drug to treat condition that causes elevated ammonia levels. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205150.htm. Accessed March 23, 2010.
6. UPDATE 1: Cytokinetics’ Lou Gehrig’s drug gets orphan status. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE6290J820100310. Accessed March 23, 2010.
7. Iprivask available for prevention of deep vein thrombosis. Monthly Prescribing Reference website. Available at: http://www.empr.com/iprivask-available-for-prevention-of-deep-vein-thrombosis/article/164779/. Accessed March 23, 2010.
8. First direct thrombin inhibitor for DVT prevention now available from Canyon Pharmaceuticals. Canyon Pharmaceuticals website. Available at: http://www.canyonpharma.com/newsexpand.aspx?id=7. Accessed March 23, 2010.
9. FDA approves Silenor. Drugs.com website. Available at: http://www.drugs.com/newdrugs/somaxon-announces-fda-approval-silenor-doxepin-insomnia-2070.html?printable=1. Accessed March 23, 2010.
10. UPDATE 1: Somaxon gets FDA nod for insomnia drug, shares soar. Reuters website. Available at: http://www.reuters.com/assets/print?aid=USSGE62H0KI20100318. Accessed March 21, 2010.
11. BioSante announces FDA orphan drug designation for GVAX pancreatic cancer vaccine. The New York Times website. Available at: http://markets.on.nytimes.com/research/stocks/news/press_release.asp?docTag=201003150755BIZWIRE_USPRX____BW5298&feedID=600&press_symbol=64917. Accessed March 23, 2010.
12. Abbott receives U.S. FDA approval for heat-stable Norvir (ritonavir) tablets. Abbott website. Available at: http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0820.htm. Accessed March 23, 2010.
13. Novo Nordisk receives FDA approval for Norditropin FlexPro for growth hormone treatment. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=239. Accessed March 23, 2010.
14. Dane L. Shire receives FDA fast-track designation for Replagal. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=97AF48EBA7054EF0857F055877E82B2C&logRowId=352323. Accessed March 23, 2010.
15. Amylin shares up on FDA response for diabetes drug. Forbes website. Available at: http://www.forbes.com/feeds/ap/2010/03/15/business-health-care-us-amylin-mover_7435579.html. Accessed March 23, 2010.
16. Russell J. MannKind drug fails to win FDA approval. Los Angeles Business Journal website. Available at: http://labusinessjournal.com/article.asp?aid=4998235.0597195.1894204.8500584.7421642.713. Accessed March 23, 2010.
17. U.S. Food and Drug Administration accepts NDA for once-daily fixed dose combination of Onglyza (saxagliptin) and extended-release metformin for the treatment of type 2 diabetes mellitus in adults. AstraZeneca website. Available at: http://www.astrazeneca-us.com/about-astrazeneca-us/newsroom/product/8804120?itemId=8804120#. Accessed March 23, 2010.
18. Dennis M. GlaxoSmithKline begins late-stage clinical programme for asthma drug Relovair. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E256469FBD8F4A2F80C5DD3E844CC1E1&logRowId=356423. Accessed March 23, 2010.