DRUGS APPROVED IN 2010

Compiled by: Naveen Kumar

Ampyra

Drug: Ampyra (dalfampridine) Indication: Multiple sclerosis Companies: Acorda Therapeutics Approval Date: January 22 Drug type: Small molecule Summary: Acorda's MS drug focused on helping patients' walking difficulties, and according to the company, is the only drug that can increase walking speeds in those affected. The drug's approval sparked almost immediate buyout rumors for Acorda. Although none came to fruition, the company has a manufacturing deal with Elan for the drug.

Asclera

Drug: Asclera (polidocanol) Indication: Varicose veins Companies: Chemische Fabrik Kresussler Approval Date: March 30 Drug Type: Small molecule Summary: The FDA approved Chemische Fabrik Kresussler's drug in March for spider veins (varicose veins smaller than 1 mm in diameter) and reticular veins (those 1 to 3 mm in diameter) in March. The drug attacks the vein's cellular wall lining, causing the vessel to close.

Carbaglu

Drug: Carbaglu (carglumic acid) Indication: NAGS deficiency Companies: Orphan Europe Approval Date: March 18 Drug type: Small molecule Summary: Despite early concerns that study designs could have interfered with drug testing results, the FDA unanimously approved Carbaglu for patients with N-acetylglutamate synthase, or NAGS, deficiency, which causes excess amounts of ammonia in the blood. The drug is a Carbamoyl Phosphate Synthetase 1 activator

Egrifta

Drug: Egrifta (tesamorelin) Indication: HIV Companies: Theratechnologies Approval Date: November 10 Drug type: Small molecule Summary: Egrifta was approved to treat lipodystrophy, a condition common in those taking antiretroviral drugs to treat HIV. Lipodystrophy causes excess fat buildup particularly in the abdominal region. The growth hormone releasing factor (GRF) drug is administered via a daily injection, and was more effective than a placebo injection in clinical trials

EllaOne

Drug: EllaOne (ulipristal acetate) Indication: Emergency contraceptive Companies: HRA Pharma, Watson Approval Date: August 13 Drug type: Small molecule Summary: Billed as the new "morning-after pill," EllaOne. Like Plan B, the pill is taken after intercourse to reduce the risk of pregnancy, but EllaOne has a five-day window instead of Plan B's three-day effective period. EllaOne received a unanimous endorsement by the FDA advisory panel one month before its approval.

Gilenya

Drug: Gilenya (fingolimod) Indication: Multiple sclerosis Companies: Novartis Approval Date: September 21 Drug type: Small molecule Summary: As the first oral MS drug, Novartis expects blockbuster results from Gilenya, estimating annual sales at up to $3.5 billion in an $11 billion-per-year market. The immunomodulator's next oral competitor is Merck KGaA's cladribine, which will be reviewed by Feb. 28.

Halaven

Drug: Halaven (eribulin mesylate) Indication: Breast cancer Companies: Eisai Approval Date: November 15 Drug type: Small molecule Summary: Just as its Alzheimer's drug Aricept was coming off patent, Eisai garnered FDA approval for its third-line breast cancer drug, Halaven. The microtubule inhibitor injectable is a synthetic version of a compound derived from a sea sponge. Patients receiving the treatment should have gone through two types of chemotherapy to combat breast cancer.

Jevtana

Drug: Jevtana (cabazitaxel) Indication: Prostate cancer Companies: Sanofi-Aventis Approval Date: June 17 Drug type: Small molecule Summary: Sanofi's microtubule inhibitor injection was approved by the FDA as a second-line treatment for metastatic hormone-refractory prostate cancer. The drug is used in conjunction with prednisone after patients have undergone docetaxel-based chemotherapy.

Krystexxa

Drug: Krystexxa (pegloticase) Indication: Gout Companies: Savient Pharmaceuticals Approval Date: September 14 Drug type: Biologics Summary: After a year of FDA woes, Savient's gout biologic Krystexxa gained approval in September. In July 2009, the second-line drug was rejected by the FDA over manufacturing concerns, which sent Savient's shares spiraling. In October, the company hit another snag after it had trouble raising the money needed to launch Krystexxa.

Lastacaft

Drug: Lastacaft (alcaftadine ophthalmic solution) Indication: Itching associated with pink eye Companies: Johnson & Johnson, Allergan Approval Date: July 28 Drug type: Small molecule Summary: J&J and Allergan's eye solution was approved by the FDA for itching associated with conjunctivitis in patients older than two years. The recommended dosage is one drop per eye per day.

Latuda

Drug: Latuda (lurasidone HCl) Indication: Schizophrenia Companies: Dainippon Sumitomo Approval Date: October 28 Drug type: Small molecule Summary: In October, the FDA approved another schizophrenia treatment, Dainippon Sumitomo's Latuda. In four six-week studies, the drug performed better than a placebo in reducing schizophrenic symptoms. Like all other atypical antipsychotics, Latuda is not approved for treatment of dementia-related psychosis.

Lumizyme

Drug: Lumizyme (alglucosidase alfa) Indication: Pompe disease Companies: Genzyme Approval Date: May 24 Drug type: Biologics Summary: After two rejections, Genzyme received FDA approval for its late-onset Pompe disease drug, Lumizyme. The gene mutation causes heart, skeletal and respiratory weakness, leading to respiratory failure and death. Lumizyme replaces the acid alpha-glucosidase (GAA) and reduce glycogen in the heart and muscle. The drug was approved with REMS, restricted distribution and a warning of anaphylaxis, severe allergic reactions and immune-mediated reactions

Natazia

Drug: Natazia (estradiol valerate and estradiol valerate/dienogest) Indication: Contraceptive Companies: Bayer Approval Date: May 7 Drug type: Small molecule Summary: The first four-phasic birth control pill, Natazia, was aproved on May 7. Bayer's newest female oral contraceptive delivers both estrogen and progestin in four varying amounts over the 28-day cycle

Pradaxa

Drug: Pradaxa (dabigatran etexilate mesylate) Indication: Atrial fibrillation Companies: Boehringer Ingelheim Approval Date: October 19 Drug type: Small molecule Summary: In the race for the bloodthinner warfarin's replacement, Boehringer took an early lead with Pradaxa's approval. Analysts believe the drug could produce $1.3 billion in revenue per year, but its competitors could come along soon: namely J&J's Xarelto and the BMS/Pfizer partner drug apixaban

Prolia

Drug: Prolia (denosumab) Indication: Osteoporosis Companies: Amgen Approval Date: June 1 Drug type: Biologics Summary: Only days after receiving European approval, and almost two months ahead of schedule, Amgen's postmenopausal osteoporosis treatment, Prolia, was approved by the FDA. The drug is administered via twiceannually injections. "We're not trying to go out there and take business away from existing drugs... but we recognize that this is a very unsatisfied group of patients that need other options," Roger Perlmutter, Amgen's EVP of research and development, told the Wall Street Journal.

Teflaro

Drug: Teflaro (ceftaroline fosamil) Indication: Skin infections, bacterial pneumonia Companies: Forest Laboratories Approval Date: October 29 Drug type: Small molecule Summary: Infection fighters have a new ally in Forest Lab's injectable antibiotic Teflaro. The cephalosporin was approved to treat community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA). Many of these serious infections are more common in healthcare settings and are resistant to more common antibiotics.

Victoza

Drug: Victoza (liraglutide) Indication: Diabetes Companies: Novo Nordisk Approval Date: January 25 Drug type: Small molecule Summary: Six after winning approval in Europe, U.S. regulators gave the okay to Novo Nordisk's potential blockbuster type II diabetes drug Victoza. The drug is an improvement over traditional therapies in that tt doesn't risk pushing blood sugar too low and promotes weight loss in patients. However, the FDA was spooked by animal data that demonstrated Victoza was linked to a greater risk of tumors, which contributed to a 21-month review process. Though Victoza's label will carry a warning for the increased risk of thyroid cancer, analysts still expect sales of the drug to peak at around $1.33 billion annually

Vpriv

Drug: Vpriv (velaglucerase alfa) Indication: Gaucher disease Companies: Shire Pharmaceuticals Approval Date: February 26 Drug type: Small molecule Summary: With Genzyme's Gaucher disease drug Cerezyme sidelined by manufacturing issues, Shire raced to regulators with its own Gaucher's treatment. And after winning approval the company set its sights on permanently wresting control of the disease market from Genzyme. Shire priced Vpriv 15 percent below Genzyme's $200,000 asking price for Cerezyme--an attractive option for insurers who'd like to save $30,000 on treating those with the rare disease

Xeomin

Drug: Xeomin (incobotulinumtoxinA) Indication: Uncontrolled muscle contractions Companies: Merz Pharmaceuticals Approval Date: July 30 Drug type: Biologics Summary: According to Merz, more than 84,000 patients have been treated with Xeomin worldwide since 2005. And last summer, the U.S. joined 19 other countries to have approved the product for the treatment of cervical dystonia and blepharospasm. Xeomin is the only botulinum toxin that does not require refrigeration prior to reconstitution, and Merz believes this may simplify product distribution and storage and ensure product integrity at the time of injection.

Xiaflex

Drug: Xiaflex (collagenase clostridium histolyticum) Indication: Depuytren's contracture Companies: Auxilium Pharmaceuticals Approval Date: February 2 Drug type: Biologic Summary: Auxilium Pharmaceuticals won the unanimous backing of an FDA advisory panel for its experimental therapy to treat Dupuytren's contracture back in the fall 2009. Roughly 7 million to 14 million people suffer from Dupuytren's disease, a buildup of collagen that leaves fingers bent with patients unable to extend them normally. "We believe the approval of Xiaflex represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture," says Auxilium CEO Armando Anido. Last winter, Auxilium scored a $15 million milestone from Pfizer, which holds the rights to sell the drug in Europe.

Glassia - 2010 CBER Approvals

Drug: Glassia (Alpha1-Proteinase Inhibitor) Indication: Treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor Company: Kamada Approval Date: July 1

Summary: Glassia is a ready-to-use liquid Alpha- 1Proteinase Inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor. In August, Baxter International announced a definitive agreement with Kamada for exclusive commercial rights to the product in the U.S., Australia, New Zealand and Canada

Hizentra - 2010 CBER Approvals

Drug: Hizentra Indication: primary immunodeficiency Company: CSL Behring Approval Date: March 4 Summary: As the first FDA-approved 20 percent subcutaneous immunoglobulin-- the highest concentration so far--Hizentra offers patients with compromised immune systems a preventative step and treatment for prevalent infections. While intravenous immunoglobulin is still the firstline standard of care for many immunodeficient patients, CSL's nonrefrigerated therapy is administered weekly via a portable pump. Hizentra is considered a replacement for CSL's previous 16 percent immunoglobulin drug, Vivaglobin, which was the only FDA-approved, self-administered treatment.

Menveo - 2010 CBER Approvals

Drug: Menveo (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine Indication: Immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Company: Novartis Approval Date: February 19 Summary: FDA approved Novartis' Menveo vaccine for use in 11-55 year olds to help protect against meningitis and sepsis caused by four common vaccinepreventable serogroups. At the time, it was anticipated that the approval could help Novartis rake in up to $650 million a year.

Prevnar-13 - 2010 CBER Approvals

Drug: Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Indication: The active immunization for the prevention of invasive disease caused by 13 serotypes of S. pneumoniae Company: Pfizer Approval Date: February 24

Summary: The FDA last February approved Pfizer's childhood vaccine Prevnar-13, which significantly expands the protection provided by Prevnar 7, a global blockbuster with $3 billion in annual sales. Analysts have pegged likely sales of Prevnar 13 at about $5 billion in 2014. Late last month, Pfizer submitted supplemental applications to the FDA and EMA to expand the use of Prevnar 13 to adults 50 years of age and older. The applications are based on six Phase III studies involving approximately 6,000 subjects.

Provenge - 2010 CBER Approvals

Drug: Provenge Indication: prostate cancer Company: Dendreon Approval Date: April 29 Summary: After a 2007 hurdle, Dendreon received FDA approval for its prostate cancer vaccine, Provenge, on April 29. And despite the $93,000 price tag for a full three-treatment course, many analysts consider the vax a future blockbuster, despite early supply delays that hampered its sales (the company pulled in $48 million in 2010). In November, a Centers for Medicare and Medicaid Services panel approved patient reimbursement for on-label usage of Provenge, which, for now, points toward more limited reimbursements when the CMS makes its final decision. With the new year came new plans as Dendreon turns its focus to European approval in 2013