2010 FDA Approvals

According to a report published by The Pharmaceutical Research and Manufacturers of America (PhRMA), 26 new medicines were approved by the U.S. Food and Drug Administration in 2010 for better prevention and treatment of disease. The new medicines include 15 new drugs (also called new molecular entities or NMEs), six new therapeutic biologics, and five other biologics. The new approvals include the following advances:

2010 Drug Approval Highlights

Two new treatments for multiple sclerosis (MS): The first treatment to help improve walking for adults with MS[i] and the first oral drug to reduce relapses and delay disability progression in MS patients.[ii]

New treatments for prostate cancer:  The first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with another standard treatment[iii] and the first cancer immunotherapy for certain men with advanced prostate cancer that stimulates their own immune system to fight the disease.  Developed specifically for each patient, the treatment is made by obtaining a patient’s immune cells from the blood using a process known as leukapheresis, then activating the cells to specifically target cancer cells in the patient.[iv]

New injectable osteoporosis medicine:  A first-in-class[v] twice-a-year medicine that works to decrease the destruction of bone and increase bone mass and strength.[vi]

New treatment to prevent stroke:  The first new oral anticoagulant in 50 years indicated to prevent stroke and blood clots in patients with abnormal heart rhythm.[vii]

The descriptions here are primarily based on information from the FDA and NIH websites. Additional information about these products, including important safety information, can be obtained from the FDA-approved package insert.

Halaven™ – eribulin mesylate (approved 11/15/2010)
For the treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic breast cancer

Egrifta™ – tesamorelin acetate (approved 11/10/2010)
For the reduction of excess abdominal fat in HIV-infected patients with lipody

Teflaro™ – ceftaloroline fosmail (approved 10/29/2010)
For the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection

Latuda® – luprasidone hydrochloride (approved 10/28/2010)
For the treatment of schizophrenia in adults

Pradaxa® – dabigatran etexilate mesylate (approved 10/19/2010)
For the prevention of stroke and blood clots in patients with atrial fibrillation

Gilenya™ – fingolimod (approved 9/21/2010)
To reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis

Krystexxa™ – pegloticase (approved 9/14/2010)
For the treatment of chronic gout in adult patients refractory to conventional therapy

Ella® – ulipristal acetate (approved 8/13/2010)
For emergency contraception

Xeomin® – incobotulinumtoxinA (approved 7/30/2010)
For the treatment of abnormal head position and neck pain that happens with cervical dystonia; for treatment of abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox)

Lastacaft™ – alcaftadine (approved 7/28/2010)
For the prevention of itching associated with conjunctivitis 

Glassia™ – alpha-1-proteinase inhibitor (approved 7/1/2010)
For the treatment of chronic augmentation and maintenance therapy in alpha1-antitrypsin deficiency, or individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor

Jevtana® Kit – cabazitaxel (approved 6/17/2010)
For the treatment of advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel; to be used in combination with prednisone

Prolia™ – denosumab (approved 6/1/2010)
For the treatment of postmenopausal women with osteoporosis who are at high risk for fractures

Lumizyme™ – alglucosidase alfa (approved 5/24/2010)
For the treatment of patients ages 8 years and older with late-onset Pompe disease

Natazia™ – dienogest; estradiol valerate (approved 5/6/2010)
For oral contraception

Provenge® – sipuleucel-T (approved 4/29/2010)
For the treatment of aysymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment

TachoSil® – fibrin sealant, absorbable patch (approved 4/2/2010)
For use as an adjunct to hemostasis in cardiovascular surgery when control of bleeding is ineffective or impractical

Asclera™ – polidocanol (approved 3/30/2010)
For the treatment of small types of varicose veins when the aim of treatment is to improve appearance

Carbaglu® – carglumic acid (approved 3/18/2010)
For the treatment of N-acetylglutamate synthase (NAGS) deficiency

Hizentra® – immune globulin subcutaneous (approved 3/4/2010)
For the treatment of primary immunodeficiency

Vpriv™ – velaglucerase alfa (approved 2/26/2010)
For the treatment of children and adults with Type I Gaucher disease

Prevnar 13™ – pneumococcal 13-valent vaccine (approved 2/24/2010)
For the prevention of invasive disease caused by 13 different serotypes of Streptococcus pneumonia

Menveo® – meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (approved 2/19/2010)
For the prevention of invasive meningococcal disease caused by Neisseria meningitides serogroups A, C, Y and W-135

Xiaflex® – collagenase clostridium histolyticum (approved 2/2/2010)
For the treatment of Dupuytren""s contracture

Victoza® – liraglutide (approved 1/25/2010)
For the treatment of type 2 diabetes

Ampyra™ – dalfampridine (approved 1/22/2010)
To improve walking in patients with multiple sclerosis

Actemra® – tocilizumab (approved 1/11/2010)
For the treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis

Includes all FDA Approvals of New Molecular Entities (NMEs) and New Biologics as of January 1, 2011

^[i]Food and Drug Administration, “FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis,” 22 January 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198463.htm
^[ii]Food and Drug Administration, “FDA Approves First Oral Drug to Reduce MS Relapses,” 22 September 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm226755.htm
^[iii]Food and Drug Administration, “FDA Approves New Treatment For Advanced Prostate Cancer,” 17 June 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216143.htm

^[iv]Food and Drug Administration, “FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer, 29 April 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm
^[v]Amgen, ” FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture,” press release, 1 June 2010, http://www.amgen.com/media/media_pr_detail.jsp?year=2010&releaseID=1433162
^[vi]Food and Drug Administration, “FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women,” 1 June 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm214150.htm
^[vii]Food and Drug Administration, “FDA Approves Pradaxa to Prevent Stroke in People with Atrial Fibrillation,” 19 October 2010, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm