Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2019/10/stewardship-resistance-scan-oct-28-2019
Stewardship / Resistance Scan for Oct 28, 2019
XDR-TB drug maker chosen; Resistant Klebsiella in Germany; New pneumonia antibiotic OK'd
Filed Under:
Tuberculosis; Healthcare-Associated Infections; Antimicrobial Stewardship; Pneumonia
[h=3]TB Alliance picks Indian firm to manufacture, commercialize pretomanid[/h] Nonprofit drug developer TB Alliance announced today that it will partner with an Indian company to manufacture and commercialize pretomanid for treating extensively drug-resistant tuberculosis (XDR-TB).
TB Alliance is granting Macleods Pharmaceuticals Limited of Mumbai a non-exclusive license to manufacture pretomanid, which was approved by the US Food and Drug Administration (FDA) in August as part of a three-drug, 6-month regimen for treatment of patients who have XDR-TB. The all-oral regimen, known as BPaL (bedaquiline, pretomanid, and linezolid), is significantly shorter than current treatment regimens for XDR-TB, which last 18 to 24 months.
"TB Alliance is committed to ensuring an affordable, sustainable and competitive market for all our new TB products," Mel Spigelman, MD, president and CEO of TB Alliance, said in a press release. "We are proud to partner with Macleods, which has a strong record of delivering high-quality, affordable tuberculosis medicines."
Pending approval from other regulatory agencies, Macleods will make pretomanid available in about 140 countries and territories.
Oct 28 TB Alliance press release
[h=3]Germany reports outbreak of carbapenem-resistant Klebsiella[/h] At least 17 patients at three German hospitals and a rehabilitation clinic have been infected with carbapenemase-producing (with resistance genes NDM-1 and OXA-48) and colistin-resistant Klebsiella pneumoniae ST307, according to a risk assessment today from the European Centre for Disease Prevention and Control (ECDC).
The outbreak is taking place in Mecklenburg-West Pomerania in northeast Germany. As of Oct 21, 6 of the 17 patients presented with clinical symptoms, while 11 were identified as carriers, the ECDC said.
"This is the first reported outbreak in Germany of K. pneumoniae that produce both NDM-1 and OXA-48 while also involving the emerging clone ST307," the ECDC said. The outbreak strain is closely related to the same carbapenemases detected earlier this year in Finland from a patient previously hospitalized in Russia, but there is no epidemiologic link between the Finnish case and the outbreak in Germany.
The ECDC said the risk to individuals outside healthcare settings is low, but the strain shows markers of increased virulence. Officials warned that not all European countries have effective screening systems in place for carbapenemase-producing Enterobacteriaceae, adding that German hospitals have put in place enhanced control measures.
Oct 28 ECDC risk assessment
[h=3]FDA approves Baxdela for community-acquired pneumonia[/h] The FDA has approved the supplemental New Drug Application (sNDA) for Baxdela (delafloxicin) for the treatment of community-acquired bacterial pneumonia (CABP), drug maker Melinta Therapeutics, Inc., announced last week, but its launch for that indication will be delayed.
FDA approval was based on the results of a phase 3 clinical trial that found that intravenous (IV)-to-oral Baxdela was noninferior to IV-to-oral moxifloxacin in early clinical response at 96 hours after initiation of therapy (88.9% vs 89%) and success at test of cure visit (90.5% vs 89.7%). Data also showed that Baxdela successfully eradicated key pathogens at rates comparable to moxifloxacin, and it was well-tolerated by study participants.
Baxdela was initially approved by the FDA in 2017 for use in patients with acute bacterial skin and skin-structure infections.
But Melinta, of Morristown, New Jersey, also said the commercial launch of Baxdela for CABP will be delayed because of the company's financial troubles.
"As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives," interim CEO Jennifer Sanfilippo, JD, said in a press release. "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."
Oct 24 Melinta press release
Stewardship / Resistance Scan for Oct 28, 2019
XDR-TB drug maker chosen; Resistant Klebsiella in Germany; New pneumonia antibiotic OK'd
Filed Under:
Tuberculosis; Healthcare-Associated Infections; Antimicrobial Stewardship; Pneumonia
[h=3]TB Alliance picks Indian firm to manufacture, commercialize pretomanid[/h] Nonprofit drug developer TB Alliance announced today that it will partner with an Indian company to manufacture and commercialize pretomanid for treating extensively drug-resistant tuberculosis (XDR-TB).
TB Alliance is granting Macleods Pharmaceuticals Limited of Mumbai a non-exclusive license to manufacture pretomanid, which was approved by the US Food and Drug Administration (FDA) in August as part of a three-drug, 6-month regimen for treatment of patients who have XDR-TB. The all-oral regimen, known as BPaL (bedaquiline, pretomanid, and linezolid), is significantly shorter than current treatment regimens for XDR-TB, which last 18 to 24 months.
"TB Alliance is committed to ensuring an affordable, sustainable and competitive market for all our new TB products," Mel Spigelman, MD, president and CEO of TB Alliance, said in a press release. "We are proud to partner with Macleods, which has a strong record of delivering high-quality, affordable tuberculosis medicines."
Pending approval from other regulatory agencies, Macleods will make pretomanid available in about 140 countries and territories.
Oct 28 TB Alliance press release
[h=3]Germany reports outbreak of carbapenem-resistant Klebsiella[/h] At least 17 patients at three German hospitals and a rehabilitation clinic have been infected with carbapenemase-producing (with resistance genes NDM-1 and OXA-48) and colistin-resistant Klebsiella pneumoniae ST307, according to a risk assessment today from the European Centre for Disease Prevention and Control (ECDC).
The outbreak is taking place in Mecklenburg-West Pomerania in northeast Germany. As of Oct 21, 6 of the 17 patients presented with clinical symptoms, while 11 were identified as carriers, the ECDC said.
"This is the first reported outbreak in Germany of K. pneumoniae that produce both NDM-1 and OXA-48 while also involving the emerging clone ST307," the ECDC said. The outbreak strain is closely related to the same carbapenemases detected earlier this year in Finland from a patient previously hospitalized in Russia, but there is no epidemiologic link between the Finnish case and the outbreak in Germany.
The ECDC said the risk to individuals outside healthcare settings is low, but the strain shows markers of increased virulence. Officials warned that not all European countries have effective screening systems in place for carbapenemase-producing Enterobacteriaceae, adding that German hospitals have put in place enhanced control measures.
Oct 28 ECDC risk assessment
[h=3]FDA approves Baxdela for community-acquired pneumonia[/h] The FDA has approved the supplemental New Drug Application (sNDA) for Baxdela (delafloxicin) for the treatment of community-acquired bacterial pneumonia (CABP), drug maker Melinta Therapeutics, Inc., announced last week, but its launch for that indication will be delayed.
FDA approval was based on the results of a phase 3 clinical trial that found that intravenous (IV)-to-oral Baxdela was noninferior to IV-to-oral moxifloxacin in early clinical response at 96 hours after initiation of therapy (88.9% vs 89%) and success at test of cure visit (90.5% vs 89.7%). Data also showed that Baxdela successfully eradicated key pathogens at rates comparable to moxifloxacin, and it was well-tolerated by study participants.
Baxdela was initially approved by the FDA in 2017 for use in patients with acute bacterial skin and skin-structure infections.
But Melinta, of Morristown, New Jersey, also said the commercial launch of Baxdela for CABP will be delayed because of the company's financial troubles.
"As previously disclosed, we are closely managing our liquidity position and continue to evaluate our potential strategic and other alternatives," interim CEO Jennifer Sanfilippo, JD, said in a press release. "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."
Oct 24 Melinta press release