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 The FDA has asked Nabriva to address issues relating to
manufacturing deficiencies at one of its contract manufacturers,
before the agency can approve the drug, the company said.
The company did not give any further details about why the drug was
not given the green light by the U.S. health regulator, but said it
would work with the FDA in coming weeks to better understand the
decision.
Nabriva's Contepo, chemically known as fosfomycin, is the first
intravenously administered drug from a new class of antibiotics
called epoxide in the United States, the company said.
Fosfomycin was first discovered in 1969 and has been used to treat a
variety of serious bacterial infections including cUTIs in countries
outside the United States.
UTI patients who fail to respond to the initial course of
antibiotics often develop a cUTI, wherein the bacteria embed in the
bladder wall and multiply, making the condition harder to address
with antibiotics.
cUTI often occurs because the right antibiotics were not prescribed,
or were not dosed appropriately. At least 20 percent of
complications are caused by multidrug resistant bacteria, severely
limiting treatment options.
Drugmakers, however, have been shying away from developing
antibiotics as combating antimicrobial-resistant pathogens,
popularly known as superbugs, has become increasingly challenging.
At least 2 million Americans develop serious infections from
antibiotic-resistant bacteria, resulting in nearly 23,000 deaths
annually, according to the Centers for Disease Control and
Prevention.
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The company is also developing another antibiotic, lefamulin, for
community-acquired bacterial pneumonia, and the FDA is expected to
announce its approval decision by Aug. 19.
Contepo and lefamulin together can treat about 8-9 million people in
the United States every year, according to the company.
Nabriva Chief Executive Officer Ted Schroeder said side effects such
as nausea and diarrhea that typically occur with the oral
formulation of fosfomycin -- sold as Monurol by Allergan Plc in the
United States and which needs to be administered at higher doses to
treat cUTIs -- are not common with Contepo.
Wedbush analyst Robert Driscoll estimates peak sales of about $118
million by 2025 for Contepo.
The FDA did not request any new clinical data and did not raise any
safety concerns regarding Contepo, Nabriva said.
(Reporting by Saumya Sibi Joseph, Tamara Mathias and Aakash
Jagadeesh Babu in Bengaluru; Editing by Sandra Maler)
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