PHARMACY

FDA approves 39 new drugs in 2012, a 16-year high

BY Jason Owen

NEW YORK — In 2012, the Food and Drug Administration approved 39 new drugs, 8 alone in December, marking the largest increase in 16 years. The wave of approvals poises pharmaceutical makers to see big gains after billions in losses in recent years to generic drug makers because of patent expirations.

2012’s tally compares to a total of 30 new drug approvals in 2011 and just 21 on 2010. At least 10 of the 39 drugs received fast-track status, which enabled them to be reviewed more quickly. 2012 saw the highest number since 1996, when 53 so-called new molecule entities received approval.

The pharmaceutical sector needs a pick-up in productivity after numerous patents expired over recent years, hitting a high-point in 2012, allowing generic manufacturers to take some of the market share with low cost substitutions. The rating agency Standard & Poor estimates major U.S. drug companies have lost about $21 billion in revenue, and European businesses lost about $10 billion, in 2012 from lucrative medicines coming off patent.

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First anti-diarrheal drug for HIV/AIDS patients receives FDA approval

BY Rebecca Haughey

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract. Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification.

The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer. The median number of daily watery bowel movements was 2.5 per day. Results showed that 17.6% of patients taking Fulyzaq experienced clinical response, compared with 8% taking placebo. In some patients, a persistent anti-diarrheal effect was seen for 20 weeks.

Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals Veregen is marketed by Florham Park, N.J.-based PharmaDerm.

 

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FDA approves J&J drug-resistant tuberculosis treatment

BY Jason Owen

WASHINGTON — The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.

Tuberculosis is an air-spread infection that usually attacks the lungs, but also affect the brain, the spine and the kidneys. The drug blocks an energy-producing enzyme the tuberculosis bacteria needs to survive and is the first drug in 40 years to attempt to cure the disease using this type of treatment.

Following a positive review by an advisory panel last month, the FDA on Monday approved the drug, chemically known as bedaquiline and to be marketed as Sirturo.

In 2011, nearly 9 million people around the world became sick with TB, according to the Centers for Disease Control and Prevention, and there were 1.4 million TB-related deaths. The disease requires six to nine months of drug treatment.

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