MannKind soars on panel recommendation for inhaled insulin
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[April 02, 2014]
MannKind Corp's shares nearly doubled
before the bell on Wednesday, after an advisory committee to the
U.S. health regulator recommended approval for the drug developer's
inhaled insulin treatment.
The panel on Tuesday voted 13-1 to recommend
approval for patients with type 1 diabetes and unanimously backed it
for those with type 2, adding that longer-term studies would still
be required to gauge the risk of lung cancer.
Analysts said that while the drug was likely to receive approval,
efficacy and safety concerns raised by the panel and the agency
could delay the decision, which is due on April 15.
"Given the number of issues flagged by FDA during the review — especially for the type 1 diabetes indication — there is still a
possibility that MannKind may be asked to conduct yet more studies
prior to approval to provide better evidence to support the targeted
patient population," Guggenheim analysts said in a note.
The FDA staff raised questions about dosing, missing data,
bronchospasms, or constriction of the air passages of the lung, and
Afrezza's effect on lung function, but raised no major new safety
concern in their review of Afrezza on Friday.
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The company's shares were trading up about 98 percent at $7.94 in
heavy premarket trading on Wednesday.
(Reporting by Natalie Grover and Vrinda Manocha in Bangalore;
editing by Saumyadeb Chakrabarty)
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