Melinta Therapeutics Announces U.S. FDA Acceptance of Supplemental New Drug Application for BAXDELA® (delafloxacin) for the Treatment of Community-Acquired Bacterial Pneumonia
~ Application Seeks to Expand Label to Include an Indication and Phase III Data for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia (CABP) ~
~ PDUFA Date Set for
"Due to the rise of antibiotic resistance and an aging population, community-acquired bacterial pneumonia, or CABP, remains a challenge for healthcare professionals and has led to a need for new treatment options,” said
The sNDA application is based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of BAXDELA to moxifloxacin for the treatment of CABP. The study results showed that BAXDELA had comparable efficacy to moxifloxacin for early clinical response and clinical outcome at test of cure. Additionally, BAXDELA was generally safe and well-tolerated. Detailed efficacy and safety results from this study will be submitted for presentation at an upcoming medical conference.
BAXDELA was approved by the
BAXDELA® (delafloxacin) tablets and intravenous injection are approved by the U.S. Food and Drug Administration (
INDICATION & USAGE
BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
IMPORTANT SAFETY INFORMATION:
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:
- Tendinitis and tendon rupture
- Peripheral neuropathy
- Central nervous system effects
Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis.
BAXDELA is contraindicated in patients with known hypersensitivity to BAXDELA or other fluoroquinolones.
Warnings and Precautions
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions. Avoid use in patients who have experienced any of the following serious adverse reactions. If these reactions occur in patients receiving BAXDELA, discontinue BAXDELA immediately and institute appropriate treatment:
- Tendinitis, tendon rupture, with increased risk in elderly, patients taking corticosteroids and in patients with organ transplants
- Peripheral neuropathy, such as pain, burning, tingling, numbness, and/or weakness or other alterations of sensation in touch and/or motor strength
- Psychiatric adverse reactions, such as toxic psychosis; hallucinations, or paranoia; depression, or suicidal thoughts or acts; delirium, disorientation, confusion, or disturbances in attention; anxiety, agitation, or nervousness; insomnia or nightmares; memory impairment
- Central nervous system adverse reactions such as seizures, increased intracranial pressure, dizziness, and tremors
- Exacerbation of myasthenia gravis, including death and requirement for ventilator
Hypersensitivity reactions have been reported in patients receiving fluoroquinolones, including BAXDELA. Reactions can be serious and occasionally fatal (anaphylactic). Discontinue BAXDELA at the first sign of hypersensitivity.
Clostridium difficile-associated diarrhea has been reported with nearly all systemic antibacterial agents, including BAXDELA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
Fluoroquinolones have been associated with an increased risk of aortic aneurysm and dissection, especially in elderly patients. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve BAXDELA for use only when there are no alternative antibacterial treatments available.
Prescribing BAXDELA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drugresistant bacteria.
Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia. Severe cases of hypoglycemia resulting in coma or death have been reported with other fluoroquinolones. Monitor blood glucose carefully in diabetic patients receiving oral hypoglycemic agents or insulin. Discontinue BAXDELA and initiate appropriate therapy immediately if a hypoglycemic reaction occurs.
The most common adverse reactions in patients treated with BAXDELA were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%).
Use in Specific Populations
In patients with severe renal impairment (eGFR of 15-29 mL/min/1.73 m2), the dosage of BAXDELA should be decreased to 200 mg IV every 12 hours or 450 mg orally every 12 hours. BAXDELA is not recommended in patients with End Stage Renal Disease [ESRD] (eGFR of <15 mL/min/1.73 m2, including hemodialysis) due to insufficient information to provide dosing recommendations.
Please see full Prescribing Information, including Boxed Warning, and Patient Medication Guide, available at www.baxdela.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions, including statements related to guidance. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made and include statements regarding: expectations with respect to our financial position, results and performance. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for Melinta include, but are not limited to, the fact that we have incurred significant operating losses since inception and will incur continued losses for the foreseeable future; our limited operating history; our need for future capital and risks related to our ability to obtain additional capital to fund future operations; risks related to the satisfaction of the closing conditions for the remaining two disbursements under the loan agreement with Vatera, including any consequences of a failure to close on the two disbursements under the Vatera loan financing; risks related to compliance with the covenants under our facilities with Vatera and Deerfield; uncertainties of cash flows and inability to meet working capital needs as well as other milestone, royalty and payment obligations, including as a result of the outcome of the pending litigation with respect to, and any requirement to make, payments potentially due under our purchase agreement with to The Medicines Company; risks that may arise from the consummation of the Vatera loan financing and the effectiveness of the amendment to the Deerfield facility agreement, including potential dilution to our stockholders and the fact that Vatera will beneficially own a substantial portion of our common stock; the fact that our independent registered public accounting firm’s report on the Company’s 2016, 2017, and 2018 financial statements contains an explanatory paragraph that states that our recurring losses from operations and our need to obtain additional capital raises substantial doubt about our ability to continue as a going concern; our substantial indebtedness; risks related to the commercial launches of our products and our inexperience as a company in marketing drug products; the degree of market acceptance of our products among physicians, patients, health care payors and the medical community; the pricing we are able to achieve for our products; failure to obtain and sustain an adequate level of reimbursement for our products by third-party payors; inaccuracies in our estimates of the market for and commercialization potential of our products; failure to maintain optimal inventory levels to meet commercial demand for any of our products; risks that our competitors are able to develop and market products that are preferred over our products; our dependence upon third parties for the manufacture and supply of our marketed products; failure to achieve the benefits of our recently completed transactions with Cempra and The
Other risks and uncertainties are more fully described in our Annual Report on Form 10-K for the year ended December 31, 2018, our Revised Definitive Proxy Statement filed January 29, 2019, and in other filings that Melinta makes and will make with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.
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Source: Melinta Therapeutics