The FDA approvals of 2009

Drug: Savella (milnacipran HCl)
Indication: Fibromyalgia
Companies: Forest Laboratories, Cypress Bioscience
Approval Date: Jan. 14

Scoop: Savella, a new fibromyalgia treatment from Forest and Cypress, was the first NME approved in 2009. Fibromyalgia is a chronic condition characterized by joint and muscle pain and decreased physical functioning that affects an estimated 6 million Americans. The safety and efficacy of Savella was established in two U.S. pivotal Phase III clinical trials involving more than 2,000 patients with fibromyalgia, according to a joint statement issued by the companies. Only two other drugs--Pfizer's Lyrica and Eli Lilly's Cymbalta--are approved to treat the condition.

Drug: Uloric (febuxostat)
Indication: Gout
Company: Takeda
Approval Date: Feb. 13

Scoop: The FDA approved the first gout treatment in 40 years when it gave its blessing to Takeda's Uloric. Back in 2005, the FDA turned down a marketing request for Uloric, noting data indicated a higher death rate and increased risk of heart problems for patients taking the therapy compared with patients receiving another gout drug. But a new and much larger Phase III trial resolved those concerns. The drug was discovered originally by Teijin Pharma.

Drug: Afinitor (everolimus)
Indication: Renal Cell Carcinoma
Company: Novartis
Approval Date: March 30

Scoop: Novartis won FDA approval last March for Afinitor tablets to treat advanced renal cell carcinoma after failure of treatment with Pfizer's Sutent (sunitinib malate) or Bayer HealthCare/Onyx Pharmaceuticals' Nexavar (sorafenib). The approval was based on data from a clinical trial showing Afinitor more than doubled the time without tumor growth when compared with placebo. It also reduced the risk of disease progression or death by 67 percent, according to a Novartis statement. The FDA had granted the product priority review. 

Drug: Coartem (artermether/lumefantrine)
Indication: Malaria
Company: Novartis
Approval Date: April 7

Scoop: An FDA advisory panel unanimously endorsed the efficacy of Coartem for malaria in December 2008, and the agency approved it the following April. Coartem was already in use in some 80 countries to treat malaria infections caused by the parasite P falciparam.

Drug: Ulesfia (benzyl alcohol)
Indication: Head Lice
Companies: Sciele
Approval Date: April 9

Scoop: Sciele, which is now known as Shionogi Pharma--a unit of the Japanese drugmaker--won approval of the head lice treatment last spring. It is the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects, according to a company statement. Sciele acquired from Summers Laboratories the rights to this product in the U.S., Canada and Mexico.

Drug: Simponi (golimumab)
Indication: Rheumatoid Arthritis
Company: Centocor Ortho Biotech
Approval Date: April 24

Scoop: Centocor, a unit of Johnson & Johnson, and Schering-Plough scored a victory last April after the FDA approved Simponi (golimumab), an injectable biologic for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. However, the partners are now fighting over the rights to Simponi as a result of the Merck/Schering-Plough merger. A marketing deal says the rights revert to J&J if Schering-Plough were subject to a change in control. But Merck and Schering-Plough designed their deal as a "reverse merger," in which Schering-Plough was the technical buyer and Merck was the company purchased.

Drug: Dysport (abobotulinumtoxinA)
Indication: Cervical Dystonia/Moderate-to-Severe Frown Lines
Companies: Ipsen/Medicis
Approval Date: April 14

Scoop: The FDA granted a license to Ipsen to sell its biologic Dysport to treat both cervical dystonia--a condition whose symptoms include involuntary contracting of the neck muscles--and to temporarily improve the look of frown lines last April. Ipsen had given fellow drugmaker Medicis the rights to develop, distribute and commercialize the product for aesthetic use by physicians in the U.S., Canada and Japan in March 2006. Like Botox, Dysport is required to carry a black box warning informing consumers of the possibility that the paralytic botulinum toxin can migrate from the site where it's injected to other parts of the body.

Drug: Fanapt (iloperidone)
Indication: Schizophrenia
Companies: Vanda
Approval Date: May 6

Scoop: Last May, the FDA approved Vanda Pharmaceuticals' Fanapt to treat schizophrenia. Vanda entered an agreement with Novartis last October that could yield the Rockville, MD-based drugmaker up to $465 million. Under the terms of the agreement, Novartis has exclusive U.S. and Canadian commercialization rights to Fanapt, which was launched Jan. 10. Vanda retains the right to commercialize Fanapt oral and depot formulations outside the U.S. and Canada.

Drug: Samsca (tolvaptan)
Indication: Hyponatremia
Company: Otsuka
Approval Date: May 19

Scoop: The FDA gave its thumbs up to Samsca last spring, making the product the only oral selective vasopressin antagonist for patients with hyponatremia, an electrolyte disorder that occurs in 6 million people in the U.S. annually. The drug helps raise serum sodium concentrations in as early as eight hours, according to Otsuka.

Drug: Besivance (besifloxacin HCl)
Indication: Bacteria Conjunctivitis
Company: Bausch & Lomb
Approval Date: May 29

Scoop: Bausch & Lomb scored a win last May when the FDA approved Besivance to treat conjunctivitis, also known as pink eye. It is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use, according to a company statement.

Drug: Ilaris (canakinumab)
Indication: CAPS
Company: Novartis
Approval Date: June 17

Scoop: The FDA approved Ilaris for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders, last June. Only 300 cases of CAPS have been diagnosed in the U.S., but there are potentially many more undiagnosed patients with the condition due to poor disease recognition. The approval marks one of the first solid commercial successes for CEO Daniel Vasella's long quest to overhaul the pharma company's pipeline.

Drug: Multaq (dronedarone HCl)
Indication: Atrial Fibrillation
Company: Sanofi-Aventis
Approval Date: July 1

Scoop: After a long dry spell, Sanofi-Aventis' pipeline produced a winner last summer, when the FDA approved the company's atrial fibrillation drug Multaq. European and Canadian regulators followed suit, approving the drug for the same indication. The FDA had rebuffed Sanofi on Multaq in August 2006, telling the drugmaker that its NDA wasn't sufficient. But Sanofi resubmitted its application with more data from the ATHENA study. The FDA granted its Multaq NDA priority review in August 2008.

Drug: Effient (prasugrel HCl)
Indication: Blood thinner for patients undergoing angioplasty
Companies: Eli Lilly/Daiichi Sankyo
Approval Date: July 10

Scoop: The FDA ended Eli Lilly and Daiichi Sankyo's quest for approval of Effient last summer-roughly a year and a half after the partners originally submitted the application (the agency had repeatedly delayed a final decision). Effient is meant to compete against the blockbuster drug Plavix (clopidogrel bisulfate), which is marketed by Sanofi-Aventis and Bristol-Myers Squibb. Early in January, Eli Lilly touted results from an economic substudy published in Circulation of the TRITON-TIMI 38 clinical trial showing that among patients with acute coronary syndromes managed with percutaneous coronary intervention, treatment with Effient compared with Plavix was more cost effective--and in most cases cost saving.

Drug: Onglyza (saxagliptin)
Indication: Type 2 diabetes
Companies: AstraZeneca and Bristol-Myers Squibb
Approval Date: July 31

Scoop: Onglyza is part of a class of drugs known as DPP-4 inhibitors, which stimulate the pancreas to make more insulin after eating a meal. It will complete with Januvia, the only other DPP-4 on the market. The FDA originally delayed action on the Onglyza so the companies could obtain more safety information from patients with kidney damage to rule out the possibility of skin-related side effects. Onglyza's approval was a major milestone for AstraZeneca; it was the company's first new drug approval in six years.

Drug: Livalo (pitavastatin)
Indication: High Cholesterol
Company: Kowa Research Institute
Date Approved: Aug. 3

Scoop: Livalo is the newest statin approved to treat high cholesterol. The drug differs from other statin in that it's more effective at inhibiting cholesterol production. And unlike other statins, it's only minimally metabolized by the liver through the cytochrome P450 pathway.

Drug: Saphris (asenapine)
Indication: Episodes related to bipolar I disorder; acute schizophrenia
Company: Organon USA (now owned by Merck)
Date Approved: Aug. 13

Scoop: Saphris is similar to current antipsychotics, but boasts an improved safety profile that could lead to blockbuster sales. It's been able to work without spurring some of the severe side effects, such as weight gain, that have plagued older antipsychotics. The drug's sales are expected to top a billion dollars a year. Saphris will compete with Risperdal from J&J and Zyprexa from Eli Lilly.

Drug: Extavia (interferon beta-1)
Indication: Symptoms of multiple sclerosis
Company: Novartis
Date Approved: Aug. 14

Scoop: Extavia is the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease. Extavia is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. Extavia is the branded version of betaseron, an older MS drug. Novartis wanted to get experience selling to the MS market in advance of the anticipaqted approval of its experimental drug FTY720.

Drug: Sabril
Indication: Infantile spasms
Company: Lundbeck
Date Approved: Aug. 21

Scoop: Lundbeck acquired Sabril when it bought out Ovation Pharmaceuticals in early 2009. The FDA approved it as a monotherapy to treat infantile spasms, making it the first treatment for children with the disease. The drug, which was already approved in Canada, was also cleared as a second-line treatment for adults with complex partial seizures. Lundbeck plans to carefully monitor Sabril patients for vision loss, which is a potential side effect of the drug.

Drug: Bepreve (bepotastine ophthalmic solution)
Indication: Ocular itching associated with allergic conjunctivitis
Company: Ista Pharmaceuticals
Date Approved: Sept. 8

Scoop: Bepreve is a treatment for itchy eyes triggered by pollen, plants and other irritants. The drug was approved in Japan in 2000, where it is marketed by Mitsubishi Tanabe Pharma. Senju Pharmaceutical as granted worldwide rights to the drug (except in Asia), and Ista in turn licensed the drug from Senju in 2006.

Drug: Vibativ (telavancin)
Indication:  MRSA-related skin infections
Company: Theravance and Astellas Pharma
Date Approved: Sept. 11

Scoop: Theravance completed trials for Vibativ in 2008. The FDA initially asked for more data on the super-bug drug but didn't require the developer to launch a new trial.  

Theravance submitted the necessary data to the FDA and won approval for the drug in September, triggering a $20 million milestone payment from partner Astellas. It was the first approval for Theravance in its 12-year history. Now the company is pursuing approval to market the treatment for hospital-acquired pneumonia.

Drug: Folotyn
Indication: Relapsed peripheral T-cell lymphoma
Company: Allos Therapeutics
Date Approved: Sept. 24

Scoop: Folotyn is the first and only drug approved for PTCL, a rare form of blood cancer that has a poor prognosis and a high relapse rate. An expert panel backed the treatment despite questions about the drugmaker's clinical data and the safety profile. Allos has faced some criticism of the drug due to it's $30,000-per-month price tag, but the company says it's priced similarly to other rare disease drugs and adds that patients only receive Folotyn for a few months.

Drug: Stelara (ustekinumab)
Indication: Moderate to severe plaque psoriasis
Company:  J&J's Centocor Ortho Biotech
Date Approved: Sept. 25

Scoop: Stelara is a biologic treatment for psoriasis developed by J&J's Centocor. The drug is administered twice in the first month, followed by dosing just four times per year. That's an improvement over other competitors like Enbrel and Humira, which require more frequent dosing. The drug is also under investigation for Crohn's  and Psoriatic arthritis. Sales of the drug are expected to top half a billion dollars by 2013.

Drug: Votrient (pazopanib)
Indication: Kidney cancer
Company: GlaxoSmithKline
Date Approved: Oct. 19

Scoop: The oral therapy is designed to stunt the growth of tumors by attacking a protein needed by the blood vessels that feed tumors. It will compete with treatments like Nexavar, but boasts different side effects that may be more acceptable to physicians and patients.

Drug: Arzerra
Indication: chronic lymphocytic leukemia
Company: GlaxoSmithKline
Date Approved: Oct. 26

Scoop: Arzerra is designed to attach to the CD20 molecule found on B cells, which are vulnerable to leukemia. It flags the cells for destruction, much like Rituxan does, though it uses a different mechanism. Arzerra is also undergoing clinical trials for rheumatoid arthritis. It was also in testing for non-Hodgkin's lymphoma, but produced underwhelming results for that indication. GSK licensed the drug, also known as ofatumumab or HuMax CD-20, in 2007 for $2.1 billion.

Drug: Istodax (romidepsin)
Indication: Cutaneous T-cell lymphoma
Company: Gloucester Pharmaceutical
Date Approved: Nov. 5

Scoop: CTCL is a rare skin malignancy that affects about 1,500 people each year. Istodax is part of a class of drugs known as histone deacetylase inhibitors, which have usually been used to treat neurological conditions. This is only the second drug in this class for cancer, and marks Gloucester's first drug approval. The company is also testing Istodax for peripheral T-cell lymphoma, as well as hematologic indications and solid tumors.

Drug: Kalbitor (ecallantide)
Indication: Sudden attacks of hereditary angioedema
Companies: Dyax
Approval Date: Nov. 27

Scoop: Last November the FDA approved Kalbitor for patients with hereditary angioedema, a rare and often lethal genetic disease characterized by pain and swelling in the face, lungs and upper airway. The approval marked a big win for Dyax, which has gone $335 million in the red as it pursued clinical development work. Kalbitor will be the 14-year-old biotech company's first marketed therapy. Dyax also licenses out its phage display technology to researchers.