This is a report from the FDA on 2011 new molecular entities (NMEs) approvals, through June 6, 2011. The total number of FDA approvals during that same period was 150. So far, 16 NMEs have been approved in five months, a sharp increase in approvals over the same period 2010.
6 NMEs NDAs were considered priorities
8 NDAs that were considered standard approvals
2 BLA (biologic products) that were not classified.
- NMEs were 10.7 percent of all approvals.
- The NME priority NDAs were 4 percent of FDA approvals.
- Priority NDAs include treatments for cancer (2 drugs), Parkinsonian syndromes, hepatitis C (2 drugs) and diarrhea.
- The one drug for HIV was classified as a standard approval
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm254242.htm
From the FDA web page:
“Spotlight on Drug Innovation”: An ongoing update of FDA’s novel new drug approvals of 2011
June 6, 2011The availability of new drugs often means new treatment options for patients, and advances in health care for the American public. For this reason, innovation is a key word throughout the pharmaceutical industry and the healthcare community. FDA regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. In this function, FDA supports innovation and plays a key role in helping to advance new drug development.
So far in 2011, FDA has approved more than 150 new brand name and generic drug products. Many are duplicate therapies that will compete in the marketplace with the same kind of products already approved. But some are new and innovative chemical structures never used before in clinical practice. Novel new drugs are often called new molecular entities (NMEs). Many of these products offer new hope for patients suffering from the conditions these products are intended to treat.
Drug Name, Active Ingredient, Date, What its used for
6 Priority NDAs
- Datscan,ioflupane i-123,1/14/2011,An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS)
- Vandetanib,vandetanib,4/6/2011,To treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms
- Zytiga,abiraterone acetate,4/28/2011,In combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy)
- Victrelis,boceprevir,5/13/2011,To treat certain adults with chronic hepatitis C.
- Incivek,telaprevir,5/23/2011,To treat certain adults with chronic hepatitis C infection
- Dificid,fidaxomicin,5/27/2011,For the treatment of Clostridium difficile-associated diarrhea (CDAD)
8 Standard NDAs
- Natroba,spinosad,1/18/2011,For the treatment of head lice infestation in patients ages 4 years and older
- Viibryd,vilazodone hydrochloride,1/21/2011,To treat major depressive disorder in adults
- Edarbi,azilsartan medoxomil,2/25/2011,To treat high blood pressure (hypertension) in adults
- Daliresp,roflumilast,2/28/2011,To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD)
- Gadavist,gadobutrol,3/14/2011,For use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system
- Horizant,gabapentin enacarbil,4/6/2011,A once-daily treatment for moderate-to-severe restless legs syndrome (RLS)
- Tradjenta,linagliptin,5/2/2011,An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Edurant,rilpivirine,5/20/2011,For the treatment of HIV-1 infection in adults who have never taken HIV therapy
2 BLAs, without review classifications
- Benlysta,belimumab,3/10/2011,To treat patients with active,autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy
- Yervoy,ipilimumab,3/25/2011,To treat patients with late-stage (metastatic) melanoma,the most dangerous type of skin cancer