Here is a look at infectious disease-related US Food and Drug Administration news from the week of July 14, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of July 14, 2019.
FDA Approves Imipenem/Cilastatin + Relebactam
On Tuesday, July 16, 2019, the FDA approved imipenem/cilastatin + relebactam (Recarbrio) for the treatment of complicated urinary tract infections and complicated intra-abdominal bacterial infections in adults who have limited or no alternative treatments available.
A new drug application (NDA) was accepted in February for the combination of relebactam, Merck’s investigational beta-lactamase inhibitor, with imipenem/cilastatin for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible gram-negative bacteria.
Recarbrio is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of cUTI, including pyelonephritis, caused by the following susceptible gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa. It is also indicated for the treatment of cIAI caused by the following susceptible gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis, and Pseudomonas aeruginosa.
Read the story in full here.
Motif Bio Seeks Type B Meeting With FDA to Discuss Additional Clinical Trial for Iclaprim
On Monday, July 15, 2019, Motif Bio announced it has submitted a meeting request and package to the FDA related to iclaprim, the company's lead product candidate for the treatment of acute bacterial skin and skin structure infections (ABSSI).
The company received a Complete Response Letter from the FDA in February, indicating that an additional clinical trial would be necessary in order to grant marketing approval. Motif Bio is now seeking a Type B meeting with the FDA to discuss study population and design.
“As we take this next step towards potential regulatory approval for iclaprim in the US, I want to recognize the efforts of our dedicated team and our clinical advisors in producing a well-considered submission package to advance our dialogue with the FDA in an expeditious manner," Graham Lumsden, CEO of Motif Bio, said in a press release. "As we continue our discussions with potential US commercial partners and evaluate potential funding options for the iclaprim clinical programme, we expect to gain greater clarity from the Agency during the Type B meeting on the pathway forward for iclaprim.”
Read the full press release here.
Seqirus First-to-Market With 2019/2020 US Influenza Vaccines
On Monday, July 15, 2019, Seqirus announced it is beginning to ship its portfolio of seasonal influenza vaccines for the upcoming 2019/2020 US influenza season.
An estimated 50 million doses are expected to hit the US market this year, the company announced. Seqirus' Fluad® is the first and only adjuvanted seasonal influenza vaccine developed for people aged 65 years and older, and Flucelvax® Quadrivalent is available for those aged 4 years and older.
"As the only global vaccine company solely dedicated to the prevention of influenza, Seqirus is proud to bring our broad portfolio of innovative vaccines to customers as part of our leading role on the front line of influenza prevention," Brent MacGregor, senior vice president of commercial operations at Seqirus, said in a press release. "We work closely with partners all year long to build on our track record of reliable supply, and we're proud to be the first influenza vaccine manufacturer to ship product to the US market during this influenza season."
Read the full press release here.