US FDA approves RECARBRIO™ for complicated UTIs and complicated intra-abdominal infections: July’s industry headlines


Take a look at this month’s industry headlines including a US FDA approval for RECARBRIO™, positive results for XOFLUZA in children and new ACIP recommendations.

 US FDA approves RECARBRIO™ for complicated UTIs and complicated intra-abdominal infections

The FDA have approved Merck’s new combination antibacterial, RECARBRIO (imipenem, cilastatin, and relebactam) for complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs) in patients that otherwise have limited or no treatment options. The antibacterial is administered by injection and is approved for infection by Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, K. pneumoniae, and Pseudomonas aeruginosa in cUTIs and a variety of Bacteroides species plus Citrobacter freundii, E. cloacae, E. coli, Fusobacterium nucleatum, K. aerogenes, K.oxytoca, K. pneumoniae, Parabacteroides distasonis and P. aeruginosa in cIAIs.

Principal investigator, Keith Kaye (University of Michigan Heath System, MI, USA) commented: “RECARBRIO provides an important addition to our toolkit in the ongoing fight against infections caused by certain Gram-negative pathogens. RECARBRIO offers an additional treatment option for patients with cIAI and cUTI who have limited and, in some cases, no alternative therapeutic options.”

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Want to hear more from Keith Kaye? Take a look at our interview with Keith on the RESTORE trial assessing relebactam in combination with imipenem >

ACIP votes to update recommendations for HPV vaccination

The Centers for Disease Control and Prevention’s (CDC; GA, USA) Advisory Committee on Immunization Practices (ACIP) has voted to recommend HPV vaccination with recombinant human papillomavirus vaccine GARDASIL®9 for individuals 27 through 45 years of age who are not adequately vaccinated. The ACIP also voted to expand routine and catch-up HPV vaccination for males up to 26 years of age who are not adequately vaccinated. The CDC currently recommends routine vaccination of both males and females 11–12 years of age, and vaccination can begin at age 9.

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ViiV Healthcare receives EU Marketing Authorization for Dovato®, a single-pill, two-drug regimen for HIV treatment

ViiV Healthcare (Brentford, UK) has received EU Marketing Authorization for Dovato a once-daily, two-drug regimen for HIV treatment for individuals with no known or suspected resistance to the integrase inhibitor class, or lamivudine. This follows approvals from the FDA and EMA in April this year.

The decision is based on the GEMINI-1 and GEMINI-2 trials where Dovato achieved non-inferiority compared to a dolutegravir-based, three-drug regimen, with no cases of resistance.

John Pottage, Chief Scientific and Medical Officer at ViiV Healthcare commented: “The Marketing Authorization of Dovato in Europe marks a significant development for people living with HIV.  This treatment allows individuals to take a two-drug regimen in a single pill with dolutegravir at the core, building on the established potency and safety profiles of dolutegravir and lamivudine.”

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Positive results announced for XOFLUZATM in children

Genentech (CA, USA) has announced positive results from the MINISTONE-2 study, the first global Phase III trial investigating one-dose XOFLUZA™ (baloxavir marboxil) in comparison with oseltamivir in children between 1 and 12 years old with influenza.

The study demonstrated that XOFLUZA, administered as a one-dose oral suspension, was safe and well-tolerated in children with flu. Moreover, it was comparable to oseltamivir in reducing the duration of flu symptoms.

Sandra Horning, Chief Medical Officer and Head of Global Product Development, commented: “As a one-dose oral suspension medicine, XOFLUZA could potentially provide a convenient treatment option for children with the flu, and we look forward to sharing these data with health authorities around the world.”

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Discover more recent news on XOFLUZA >

Sanofi gains US rights to over-the-counter version of Tamiflu

Sanofi has signed an agreement allowing them to gain exclusive US rights to the over-the-counter version of Roche’s influenza drug Tamiflu (oseltamivir). In light of this deal, Sanofi will be responsible for leading FDA negotiations for the over-the-counter switch and subsequent marketing and distribution of the product.

Alan Main, Executive Vice President of Sanofi’s consumer healthcare unit, commented: “This is a strategic and important transaction for us, a successful switch of Tamiflu to over-the-counter would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market.”

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ACIP votes to expand routine hepatitis A vaccination

ACIP has voted to recommend that all children between 2 and 18 years who have not previously received a hepatitis A vaccine be vaccinated routinely at any age. Moreover, ACIP unanimously recommended updating the language around the utilization of hepatitis A vaccine in the ‘Vaccines for Children program’.

This updated recommendation is in addition to the current CDC recommendation for the routine vaccination of children aged 12–23 months. The recommendations are now under review by the director of the CDC and the Department of Health and Human Services.

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ViiV Healthcare announces launch of first-ever study evaluate its once-monthly injectable HIV treatment in clinical practice

ViiV Healthcare has announced that its long-acting infectable regimen has been granted Priority Review by the FDA, with an approval targeted in December 2019. The CUSTOMIZE trial will aim to identify and evaluate approaches to implementing the company’s once-monthly injectable HIV treatment in clinical practice, lasting for 1 year. The goal is to find practical and efficient ways to implement a monthly injectable regimen if approved, including how to build capacity for increased clinic visits.

Harmony Garges, Head of Global Medical Affairs at ViiV Healthcare, commented: “With the CUSTOMIZE study, ViiV Healthcare is aiming to identify and evaluate different approaches to implementing a monthly injectable HIV treatment in the real world, which can be different from the controlled setting of a clinical trial. Experts believe effective implementation of HIV treatment could have the greatest contribution towards ending the HIV epidemic and we believe this study is an important step towards that goal.”

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Want to learn more about the future of long-acting formulations for HIV treatment? Take a look at our interview with Jose Arribas >

Johnson & Johnson to initiate study of investigational tetravalent HIV vaccine

Johnson & Johnson (NJ, USA) has confirmed the launch of a Phase III study assessing their experimental heterologous vaccine regimen later this year. The MOSAICO trial is expected to include approximately 3800 men who have sex with men, and the study results are expected as soon as 2023.

Paul Stoffels, Chief Scientific Officer, commented: “The cost of treating HIV patients – the burden for patients, the burden for society – is very high,” adding that HIV prevention remains “a big mission for us. We’ve been working on it for almost 30 years.”

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You can find more information on HIV in industry from the IAS conference, including:

Enrollment begins for second cohort of BiondVax’s Phase III universal flu vaccine trial

The first participants in the second cohort of the Phase III trial assessing the M-001 universal flu vaccine have been successfully enrolled, according to BiondVax Pharmaceuticals Ltd. (Ness Ziona, Israel). The trial is assessing the safety and effectiveness of the M-001 vaccines in reducing flu severity in approximately 12,000 adults aged 50 years or older. The first cohort enrolled 4094 individuals prior to the 2018–2019 flu season, and after a safety review the trial has now been allowed to enroll the second cohort containing 8000 participants for the 2019–2020 flu season. Results are expected in late 2020.

Tamar Ben-Yedidia, BiondVax’s Chief Science Officer, commented: “The Phase III trial of our universal flu vaccine is being conducted for two flu seasons over a broad geographic area, and vaccination began this year in July, well before the usual onset of flu season. The current study aims to demonstrate how well M-001 protects the participants against flu illness when they are exposed to any circulating flu strain.”

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Want to find out more? Learn about UNISEC: Towards a universal flu vaccine in an interview with Ed Schmidt >

Gilead licenses three preclinical antiviral programs from Novartis

Gilead Sciences (CA, USA) has licensed three preclinical antiviral programs from Novartis (Basel, Switzerland), including investigational treatments for rhinovirus, herpes and influenza. Gilead will gain exclusive rights to develop and market novel molecules against three undisclosed targets.

Gilead’s Chief Scientific Officer, John McHutchison, stated: “Today’s announcement builds on Gilead’s heritage in antiviral [R&D]. We look forward to applying this expertise to advance the development of potential new treatments for viruses with limited therapeutic options.”

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Missed last month’s headlines? Catch up now:

Funding received for first Phase III trial of a chikungunya vaccine: June’s industry headlines


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