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 The panel voted unanimously that Cubist
Pharmaceuticals Inc's tedizolid and Durata Therapeutics Inc's
dalbavancin showed substantial evidence of safety and efficacy.
The votes pave the way for approval of the drugs. The FDA is not
obliged to follow the advice of its expert panels but typically does
so. Cubist's shares closed up 4.4 percent at $73.15. Durata's shares
rose 1.4 percent to $13.65 in after-hours trading.
The drugs are 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. The drugs are aimed at serious Gram-positive
infections, including methicillin-resistant Staphylococcus aureus,
or MRSA.
Tedizolid, which would be sold under the brand name Sivextro if
approved, would be given once daily either intravenously or orally.
Dalbavancin, which would be sold under the brand name Dalvance if
approved, would be given in two doses, the first on day one and the
second on day eight.
Panelists said they would like to see both companies conduct further
safety studies once the drugs reach the market, but they agreed that
the drugs would be useful new treatments.
Cubist's tedizolid can be dosed less frequently, given for shorter
periods of time, and may have fewer side effects than linezolid, a
rival treatment marketed by Pfizer Inc in the United States under
the brand name Zyvox, they said.
"This is clearly an effective drug which will add to our
armamentarium," said Dr. Thomas Moore, a panelist and clinical
professor at the University of Kansas School of Medicine.
If approved, the drug is expected to generate annual sales of $219
million by 2019, according to the average estimate of six analysts
polled by Thomson Reuters.
Results from its clinical development program showed tedizolid was
not inferior to linezolid in terms of efficacy and could be given
once a day for six days compared with linezolid's dosage of twice a
day for 10 to 14 days.
Trials of dalbavancin showed the drug was not inferior when compared
with a control group that included vancomycin or vancomycin followed
by linezolid.
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One analyst polled by Thomson Reuters sees dalbavancin sales
reaching $449 million by 2019.
The main treatment for MRSA today is vancomycin, which is given
intravenously and available generically. Cubist also sells another
anti-infective, Cubicin, which generated global sales of more than
$1 billion in 2013.
Panelists said they had some concerns about the potential for
dalbavancin to cause liver problems, especially in patients with
underlying liver disease, and recommended the company be required to
conduct additional safety studies once the drug is on the market.
They also urged the FDA to work with the company to develop
guidelines for patient follow-up after the initial dose has been
given to ensure patients receive the critical second dose.
"I'm wondering how many people will get a shot of this, go out the
door and never come back," said Dr. Michael Neely, a panelist and
associate professor of pediatrics at the University of Southern
California.
The urged that Cubist's drug be studied for safety over a longer
period than that studied in the trial.
Cubist, based in Lexington, Massachusetts, acquired tedizolid with
its 2013 purchase of Trius Therapeutics for about $704 million.
Durata is based in Chicago.
(Reporting by Toni Clarke in Washington;
editing by Bill Trott, Paul
Simao and Steve Orlofsky)
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