~ Approval Based on Positive Phase III Trial Results of BAXDELA for Treatment of CABP in Adults~
~ Company Delays Launch of CABP Indication Until Further Visibility Into Liquidity Position ~
MORRISTOWN, NJ, USA I October 24, 2019 I Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (FDA) has approved BAXDELA® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. This supplemental approval follows FDA priority review based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections.
“We are pleased to announce the approval of BAXDELA for the treatment of CABP in adults,” said Jennifer Sanfilippo, interim chief executive officer of Melinta. “As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives. As such, while we believe that BAXDELA will play a significant role in the treatment of this potentially life-threatening illness, we are delaying the commercial launch of CABP until we have greater insight into our ability to secure additional sources of liquidity.”
The FDA approval of BAXDELA for the treatment of CABP is based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of BAXDELA to moxifloxacin. The study results demonstrated that BAXDELA met all key primary and secondary endpoints in the trial. In the intent-to-treat population (ITT), IV-to-oral BAXDELA met the FDA primary endpoint of statistical non-inferiority for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in BAXDELA patients) compared to IV/oral moxifloxacin (89.0%).
BAXDELA also met the FDA secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator’s assessment of Success at the Test of Cure visit (5-10 days after last dose) in the ITT population. Data further showed that IV/oral BAXDELA successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin. Both intravenous (IV) and oral BAXDELA were well-tolerated among study participants. Overall adverse event rates were similar between treatment arms. The most common treatment-emergent adverse events in the BAXDELA arm (≥ 2%) were diarrhea and transaminase increases, which were generally mild and did not lead routinely to treatment discontinuation.
BAXDELA was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela® (delafloxacin), Vabomere® (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. This portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
About BAXDELA® (delafloxacin)
BAXDELA® tablets and intravenous injection are approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults caused by designated susceptible bacteria. BAXDELA was approved for the treatment of ABSSSI by the FDA in 2017 based on its efficacy against both gram-positive and gram-negative pathogens, including MRSA, and for the treatment of CABP in October 2019 based on its efficacy against gram-positive, gram-negative and other microorganisms. It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies BAXDELA for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
INDICATION & USAGE
BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: 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, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
BAXDELA is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.
SOURCE: Melinta Therapeutics
Post Views: 83
~ Approval Based on Positive Phase III Trial Results of BAXDELA for Treatment of CABP in Adults~
~ Company Delays Launch of CABP Indication Until Further Visibility Into Liquidity Position ~
MORRISTOWN, NJ, USA I October 24, 2019 I Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (FDA) has approved BAXDELA® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. This supplemental approval follows FDA priority review based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections.
“We are pleased to announce the approval of BAXDELA for the treatment of CABP in adults,” said Jennifer Sanfilippo, interim chief executive officer of Melinta. “As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives. As such, while we believe that BAXDELA will play a significant role in the treatment of this potentially life-threatening illness, we are delaying the commercial launch of CABP until we have greater insight into our ability to secure additional sources of liquidity.”
The FDA approval of BAXDELA for the treatment of CABP is based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of BAXDELA to moxifloxacin. The study results demonstrated that BAXDELA met all key primary and secondary endpoints in the trial. In the intent-to-treat population (ITT), IV-to-oral BAXDELA met the FDA primary endpoint of statistical non-inferiority for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in BAXDELA patients) compared to IV/oral moxifloxacin (89.0%).
BAXDELA also met the FDA secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator’s assessment of Success at the Test of Cure visit (5-10 days after last dose) in the ITT population. Data further showed that IV/oral BAXDELA successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin. Both intravenous (IV) and oral BAXDELA were well-tolerated among study participants. Overall adverse event rates were similar between treatment arms. The most common treatment-emergent adverse events in the BAXDELA arm (≥ 2%) were diarrhea and transaminase increases, which were generally mild and did not lead routinely to treatment discontinuation.
BAXDELA was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela® (delafloxacin), Vabomere® (meropenem and vaborbactam), Orbactiv® (oritavancin), and Minocin® (minocycline) for Injection. This portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
About BAXDELA® (delafloxacin)
BAXDELA® tablets and intravenous injection are approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults caused by designated susceptible bacteria. BAXDELA was approved for the treatment of ABSSSI by the FDA in 2017 based on its efficacy against both gram-positive and gram-negative pathogens, including MRSA, and for the treatment of CABP in October 2019 based on its efficacy against gram-positive, gram-negative and other microorganisms. It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies BAXDELA for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
INDICATION & USAGE
BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: 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, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
BAXDELA is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.
SOURCE: Melinta Therapeutics
Post Views: 83
