New Drug Approvals in 2013: What Was Hot, What Was Not
Dimethyl fumarate (Tecfidera) by Biogen Idec
Analysts say the highly anticipated Tecfidera could have sales of up to $6 billion annually by 2020. A year's supply of Tecfidera will run close to $55,000. Other oral competitors include Aubagio and Gilenya.
Canagliflozin by Janssen Pharmaceuticals
The FDA Advisory Committee expressed concern over cardiovascular safety, but the FDA followed-up by ordering five post-marketing safety trials looking at cardiovascular safety to cancer risk. Nonetheless, some analysts predict this drug to be a blockbuster by 2018.
Elvitegravir by Gilead
Gilead is also seeking approval of the pharmacokinetic enhancer cobicistat as a single entity agent. On April 29, 2013 Gilead received the Complete Response Letters from the FDA for both elvitegravir and cobicistat; deficiencies were found in the NDA. Approval is pending.
Cobicistat by Gilead
Cobicistat inhibits CYP3A4, an enzyme responsible for breaking down some HIV drugs, but it is not active against HIV itself. The NDA was submitted in June 2012, but initial approval was rejected in 2013 due to deficiencies in documentation and validation of certain quality testing procedures and methods. The FDA did not raise safety concerns about the drug.
Buprenorphine (Probuphine) by Titan Pharmaceuticals
Buprenorphine, already approved and well-accepted for the treatment of opioid dependence surpassed 2011 U.S. sales of $1.3 billion. On April 30, 2013, the FDA issued a complete response letter stating they could not approve the application in its present form; they required additional data supporting the efficacy of Probuphine.
Fluticasone furoate/vilanterol (Breo Ellipta) by GSK & Theravance
COPD is a chronic lung disease that worsens over time. Cigarette smoking is the leading cause of COPD and is the third leading cause of death in the United States.
Gabapentin Extended Release (Sefelsa) by DepoMed
However, at the FDA Advisory Committee meeting in March 2013 the committee voted 2-12 against approval for Sefelsa. A complete response letter was received at the end of May and Depomed has halted production of Sefelsa.
Dabrafenib (Tafinalar) by GlaxoSmithkline
Dabrafenib, a BRAF inhibitor, blocks kinase to inhibit cancer cell growth. Vemurafenib (Zelboraf) by Genentech is currently approved for a similar use. In May 2013, Tafinalar was approved along with a diagnostic genetic test to identify patients for treatment.
Trametinib (Mekinist) by GlaxoSmithkline
In addition, GSK has ongoing clinical trials looking at the use of dabrafenib and trametinib in combination to delay or prevent cancer recurrence in this high-risk group after melanoma surgical removal.
Tivozanib by AVEO and Astellas
In May, 2013, an FDA Advisory Committee voted 13 to 1 against approval of tivozanib, stating the NDA for tivozanib did not demonstrate a favorable benefit-to-risk ratio for treatment of metastatic renal cell carcinoma. In June 2013 the FDA rejected AVEO Oncology's NDA for tivozanib due to an imbalance in progression-free and overall survival results.
Levomilnacipran ER (Fetzima) by Forest Labs
On July 25, 2013 the FDA approved levomilnacipran for MDD. It will be available as a once-daily, extended-release capsule in 40, 80 or 120 mg strengths. Forest Labs expects Fetzima to be launched to retail stores in 4th quarter 2013.
Dolutegravir by ViiV Healthcare
Dolutegravir is expected to be a major competitor for Gilead's HIV treatment Atripla and Merck's Isentress.
Bazedoxifene/Conjugated Estrogens (Duavee) by Pfizer & Ligand Pharma
Duavee pairs a selective estrogen receptor modulator bazedoxifene with estrogen, and is the first TSEC. Brisdelle (paroxetine), also approved by the FDA in 2013, is the first non-hormonal treatment for hot flashes associated with menopause.
Methotrexate Injection (Otrexup) by Antares Pharma
Macitentan (Opsumit) by Actelion
Umeclidinium bromide/vilanterol (Anoro) by GlaxoSmithkline/Theravance
Sofosbuvir by Gilead
Suvorexant by Merck
In July, the FDA rejected Merck's NDA, saying a lower 10-mg start dose should be developed; the 15 and 20 mg doses would be appropriate if the 10 mg dose is well-tolerated but not effective. Approval could be delayed by up to one year. Analysts predict sales peak may range from $700 million to $1.5 billion for suvorexant by 2018.
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- Carroll JD. FierceBiotech. Blockbuster Buzz: 15 top therapies in late-stage development. Accessed 4/7/2013. http://www.fiercebiotech.com/special-reports/blockbuster-buzz-15-top-therapies-late-stage-development
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