June 20 The U.S. Food and Drug Administration
said on Friday it approved a new drug to treat acute bacterial
skin infections made by Cubist Pharmaceuticals Inc.
The drug, Sivextro, is designed to treat serious acute
bacterial skin and skin structure infections, or ABSSSI. These
are infections that involve deep tissue or are associated with
an underlying disease such as diabetes.
Approval of Sivextro, known also as tedizolid, follows on
the heels of the FDA's approval of a drug for the same condition
made by Durata Therapeutics Inc known as Dalvance, or
The drugs target Gram-positive infections, including
methicillin-resistant Staphylococcus aureus, or MRSA. Sivextro
is given once daily for six days. Dalvance is given in two
doses, eight days apart.
"MRSA is still problematic in the U.S. and is responsible
for the deaths of more than 11,000 Americans each year," Dr.
Ralph Corey, professor of medicine and infectious disease at
Duke University Medical Center, said in a statement. "Not every
antibiotic will work for every patient and more drug options are
The main treatment for MRSA is vancomycin, which is
Sivextro received an expedited review by the FDA and was
designated a qualified infectious disease product, meaning it
qualifies for an extra five years of marketing exclusivity.
The most common side effects of the drug were nausea,
headache, diarrhea, vomiting and dizziness.
(Reporting by Toni Clarke in Washington; Editing by Leslie