NDA submitted for new antibiotic for hospital-treated skin infections
Melinta Therapeutics yesterday submitted a New Drug Application (NDA) to the US Food and Drug for the approval of intravenous and oral Baxdela (delafloxacin), an antibiotic for the treatment of bacterial skin and skin structure infections.
Baxdela is an investigational anionic fluoroquinolone for hospital-treated skin infections that acts against a broad spectrum of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The NDA is based on the results of two phase 3 studies in which the drug met the primary endpoint—non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size within 48 to 72 hours—and was well tolerated. The most common side effects were mild diarrhea and nausea.
"Baxdela, if approved, represents a potentially attractive treatment option for the nearly 3 million patients hospitalized annually in the U.S. with serious skin infections," Melinta CEO Eugene Sum, MD, said in a press release. "These patients have a high rate of treatment failure, and frequently have underlying medical conditions that pose challenges to the choice of antibiotic."
Baxdela has been designated a Qualified Infectious Disease Product by the FDA, a designation that accelerates the approval process.
Oct 24 Melinta Therapeutics press release
Nation's first cholera vaccine available for US travelers
Following June approval by the FDA, PaxVax announced yesterday that its cholera vaccine is now available in the United States as the country's only vaccine against the disease.
The FDA's approval was followed by a recommendation from the Advisory Committee on Immunization Practices (ACIP) that Vaxchora—given as a single oral dose—be used for people traveling to areas experiencing active cholera transmission.
Nima Farzan, chief executive officer and president of PaxVax, based in Redwood City, Calif., said in a statement that the availability of the vaccine is especially timely, given the flow of US military and citizens going to Haiti to assist with hurricane relief efforts. "Vaccinating those traveling to cholera-affected areas can help mitigate its spread and can help protect them against the disease," he said.
The company noted that it has made a donation to Partners in Health, a relief organization, to support cholera response activities in Haiti.
Oct 24 PaxVax statement
Jun 13 CIDRAP News story "Single-dose oral cholera vaccine is first to get US approval"
In other cholera developments, the United Nations (UN) said yesterday that it hopes to raise $200 million to help Haitian families and communities affected by an earlier cholera outbreak, Reuters reported yesterday. David Nabarro, MD, special advisor to the UN, said at a media briefing taht half would go to families and half would go to communities, and that the funds would likely come from extra money from the UN budget's routine assessments to 193 member countries.
According to the report, the plan would also earmark $200 million for rapid response teams and efforts to rebuild the country's water and sanitation systems.
Over the summer UN officials took responsibility for its role in introducing the disease to Haiti, which occurred when sick UN peacekeepers from Nepal dumped human waste into the Artibonite River. The group's move came as a US court affirmed its immunity from a damage claim filed by Haiti's cholera victims.
Oct 24 Reuters story
H5N8 outbreaks expand to southern India
India's media today reported a fourth highly pathogenic H5N8 avian flu outbreak, signaling rapid spread of the virus, this time into far southern Kerala state.
According to a Times of India report posted by the Avian Flu Diary blog, the virus was confirmed in five places in ducks in Kerala state's Alappuzha district. The findings were confirmed by the State Disease Investigation Laboratory in Bhopal. Health officials have established 20 rapid response teams to battle the virus.
The findings follow confirmations over the past few days of H5N8 in birds at two zoological gardens in New Delhi and a similar facility about 100 miles southeast of there in Madya Pradesh state.
In September the UN Food and Agriculture Organization (FAO) urged certain regions to be alert for H5N8 following the June detection of the virus in Russian waterfowl.
Oct 25 Avian Flu Diary post
Oct 24 CIDRAP News scan "H5N8 strikes 2 more Indian zoos; Bhutan reports H5N1 outbreak"
Study finds treatment failure pattern for malaria treatment combo
Swedish researchers yesterday reported a high rate of late treatment failures in malaria patients treated with artemether-lumefantrine (AL), one of the artemisinin-based combination therapies for the disease. The team published its findings in Clinical Infectious Diseases.
The researchers based their analysis on the outcome of treatment regimens for adults with Plasmodium falciparum in Stockholm adults between 2000 and 2015, with an eye toward gauging the effectiveness of a six-dose AL regimen.
Of 397 P falciparum illnesses, 310 received oral-only treatment, 95 of them with AL. They identified five late-treatment failures for AL, along with one for atovaquone-proguanil. Overall, researchers found that effectiveness for AL was slightly lower than for other oral regimens: 94.7% compared with 99.5%.
AL failures were more likely to occur in European men, in whom effectiveness was 73.7%. Genotyping found initial parasite levels rebounded, but with no sign of drug-resistance markers. Blood concentrations of lumefantrine were subtherapeutic in at least two of the cases.
The team concluded that the findings show a need to establish optimal dosing for AL in adults.
Oct 24 Clin Infect Dis abstract
El Nino linked to increased infectious diseases in some US regions
The climate condition known as El Nino southern oscillation (ENSO) is associated with increased tick-borne and enteric (gastrointestinal) disease in some regions of the United States, according to a study yesterday in Proceedings of the National Academy of Sciences.
Infectious disease experts from Canada and the United States studied hospital data and ENSO patterns from 1970 to 2010 and looked at five disease groups: (1) vector-borne diseases, (2) pneumonia and influenza, (3) enteric disease, (4) zoonotic bacterial disease, and (5) fungal disease. They used mathematical models that factored in lag times for the possible effect of weather patterns on disease incidence.
The investigators found that ENSO was associated with an almost tripled incidence of vector-borne disease in the Western region but a slight decline in enteric disease in that region. They determined that the increase was attributable to a spike in rickettsioses and other tick-borne infections.
In contrast, ENSO was associated with more enteric disease in non-Western regions, particularly in the Northeast.
The authors conclude, "The impact of ENSO suggests that warmer temperatures and extreme variation in precipitation events influence risks of vector-borne and enteric disease in the United States."
Oct 24 Proc Natl Acad Sci abstract