News Feature | June 5, 2014

New MRSA Drug Approved By FDA

By Marcus Johnson

The FDA has announced that it has approved a new drug, Dalvance, to fight against the dangerous MRSA skin infection. Methicillin-resistant Staphylococcus aureus, better known as MRSA, is a skin infection that is caused by a particular strain of staph bacteria. Because the staph strain that causes MRSA is resistant to the majority of antibiotics, it is currently very difficult to treat, and is considered life threatening. MRSA can be contracted where there is close skin to skin contact with other individuals or if unsterilized medical equipment comes into contact with patients. Athletic settings and medical environments, such as hospitals, are known for having higher rates of MRSA infections.

Dalvance is produced by Durata Therapeutics, which is based out of Chicago. The drug has only been approved for use in adults, and is taken intravenously. Dalvance is the first drug labeled as a Qualified Infectious Disease Product through the FDA’s Qualified Infectious Disease Product (QIDP) program to be approved by the FDA. The QIDP program was started in order to make sure that antibiotic-resistant infections would get proper research from pharmaceutical companies. The program offers an expedited review process as well as an extra five years of marketing exclusivity for the approved drug. Dalvance had two clinical trials that enrolled a total of 1,289 patients.

Industry experts believe that drugs such as Dalvance will become more of a necessity in the near future. The World Health Organization recently said that antibiotic-resistant infections are considered a serious threat, even going as far to say that “these infections could derail the very achievements of modern medicine.” According to data provided by the CDC, over 2 million people each year are infected with antibiotic-resistant bacteria, and about 23,000 of those individuals die each year because of the infection. There isn’t data on how many more die because of complications indirectly caused by the infection, but researchers believe that number is much higher.