Nabriva Therapeutics plc NBRV announced that the FDA has approved its new drug application (NDA) for both intravenous (IV) and oral formulations of Xenleta (lefamulin) to treat adult patients with community-acquired bacterial pneumonia (CABP).
Notably, last December, Nabvira submitted two NDAs to the FDA for both IV and oral formulations of lefamulin to treat CABP in the United States.
The approval was based on data from two pivotal phase III studies (known as LEAP 1 and LEAP 2), which evaluated the safety and efficacy of Xenleta compared to moxifloxacin for treating the given patient population. The drug was generally well tolerated in both studies.
Following the nod, Xenleta became the first IV and oral antibiotic monotherapy treatment option for adults with CABP to be approved by the FDA in nearly two decades. The drug is available for oral (600 mg) as well as IV (150 mg) formulations, both to be administered every 12 hours in patients with CABP for a period of five to seven days.
Nabriva plans to make Xenleta available mid next month through specialty distributors in the United States. The wholesale acquisition cost (WAC) of the drug would be $205/day for treating patients with IV formulation and $275/day for oral treatment.
Meanwhile, in June this year, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA), seeking approval for both IV and oral formulations of lefamulin to treat community-acquired pneumonia (CAP) in adult patients.
If approved, lefamulin will be available across all the 28 member states of the EU along with Norway, Liechtenstein and Iceland.
Shares of Nabriva have soared 51.4% so far this year against the industry’s decline of 2%.
We would like to remind investors that Nabvira has another candidate in its portfolio called Contepo (fosfomycin), which is a potentially first-in-class epoxide intravenous antibiotic developed for treating adult patients with complicated urinary tract infection (cUTI).
Yesterday, the company announced that it plans to resubmit an NDA for Contepo injection to the FDA early in the fourth quarter of 2019 for treating patients with cUTI including acute pyelonephritis.
The decision was made following the receipt of the final Type A Meeting minutes from the regulatory body.
Zacks Rank & Other Stocks to Consider
Nabvira currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the healthcare sector include FibroGen, Inc FGEN, Eagle Pharmaceuticals, Inc. EGRX and Alexion Pharmaceuticals, Inc. ALXN, while FibroGen and Eagle Pharmaceuticals sport a Zacks Rank #1 (Strong Buy), Alexion has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
FibroGen’s loss per share estimates have been narrowed 57.5% for 2019 and 64.2% for 2020 over the past 60 days.
Eagle Pharmaceuticals’ earnings estimates have been revised 5.2% upward for 2019 and 1.2% for 2020 over the past 60 days. The stock has surged 46.3% year to date.
Alexion’s earnings estimates have been revised 4.2% upward for 2019 and 2.1% for 2020 over the past 60 days. The stock has rallied 15.8% year to date.
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