Drugs approved by US FDA in 2010

1. DRUGS APPROVED IN
2010
Compiled by: Naveen Kumar

2. 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.

3. 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.

4. 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

5. 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

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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

14. 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

15. 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

16. 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 twice-
annually 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.

17. 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.

18. 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

19. 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

20. 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.

21. 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.

22. 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- 1-
Proteinase 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

23. 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 first-
line 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.

24. 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 vaccine-
preventable serogroups. At the time, it was anticipated
that the approval could help Novartis rake in up to $650
million a year.

25. 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.

26. 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