Authors: Martha Powell, Future Science Group
Take a look at this month’s industry headlines including US FDA approvals for Mavyret (hepatitis C) and the dengue vaccine Dengvaxia, profits for Gilead Sciences and new grants for antibiotic development.
- FDA approves first treatment for all genotypes of hepatitis C in pediatric patients
- FDA rejects Nabriva’s antibiotic Contepo for complicated urinary tract infections
- Generic version of PrEP drug Truvada available by September 2002, says Gilead
- FDA approves first dengue vaccine but limits use
- Gilead reports increased Q1 revenue due to HIV products
- T2Bacteria panel shows promise for rapidly and accurately diagnosing ESKAPE pathogens
- China approves GSK’s shingles vaccine, Shingrix
- Merck receives Breakthrough Therapy designation from FDA for pneumococcal vaccine V114
- Hackensack Meridian Health receives $33.3 million from NIH to develop new antibiotics
- Polyphor halts enrollment in Phase III studies of antibiotic murepavadin after high rate of kidney injury
- Dynavax Technologies to focus on hepatitis B vaccine, Heplisav-B
FDA approves first treatment for all genotypes of hepatitis C in pediatric patients
The US FDA has approved Mavyret (glecaprevir and pibrentasvir) tablets for the treatment of all six genotypes of hepatitis C in children aged 12–17. Mavyret, which is produced by AbbieVie Inc (IL, USA), was previously approved to treat HCV in adults in 2017.
Jeffrey Murray, Deputy Director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, commented: “Today’s approval represents another treatment option for children and adolescents with hepatitis C infection, but for the first time, in all genotypes of HCV.”
FDA rejects Nabriva’s antibiotic Contepo for complicated urinary tract infections
Nabriva Therapeutics (Dublin, Ireland) have announced that the FDA issued a complete response letter regarding the approval of Contepo (fosfomycin) for the treatment of complicated urinary tract infections.
In the letter the FDA raised issues related to facility inspections and manufacturing deficiencies at a contract manufacturer. Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics, commented: “We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments related to the CONTEPO Complete Response Letter, with the goal of bringing this important treatment to patients as quickly as possible.”
Generic version of PrEP drug Truvada available by September 2002, says Gilead
A generic version of the HIV preexposure prophylaxis (PrEP) drug Truvada will be available in the United States by September 2020, a year earlier than expected, according to Gilead Sciences (CA, USA).
Currently a month’s supply of generic Truvada is available in some countries around the world for as little as US$70, however in the USA the drug costs US$1,600– $2,000. The information about generic Truvada, which was previously not expected until 2021 is disclosed on page 35 of a Gilead SEC filing and the early availability has been attributed to activists in the USA campaigning to make the generic drug more widely available.
FDA approves first dengue vaccine but limits use
The US FDA announced its approval of Dengvaxia for individuals aged 9–16 who have had a laboratory-confirmed previous case of dengue and live in endemic areas after Priority review. This is the first dengue vaccine to be approved, however, use of the vaccine, which is produced by Sanofi Pasteur (Paris, France), has been restricted following post-marketing surveillance by Sanofi demonstrating that while the vaccine protects individuals who have already had a dengue infection it increased the risk of dengue in dengue-naïve children.
Last year, the European Commission approved the vaccine for use in dengue endemic parts of Europe in individuals aged 9–45 who had had at least one case of dengue infection, however, the FDA voted against the vaccine’s use in this population in March 2019.
Despite this being a smaller market than previously hoped, Sanofi stated it was pleased by the FDA decision. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research commented: “Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death.
“As the second infection with dengue is often much more severe than the first, the FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease.”
Gilead reports increased Q1 revenue due to HIV products
Gilead Sciences (CA, USA) has reported a higher profit in quarter one, noting that its HIV sales in the first quarter were primarily due to higher sales volume as a result of the continued uptake of Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide). However, the company also reported that hepatitis C revenue was depressed, perhaps owing to lower patient starts and competitive dynamics, including a decline in price in US Medicare in 2019.
Mizuho analyst Salim Syed commented that the performance of Biktarvy in the quarter, which is patent-protected until 2033, “plays into the Gilead thesis in the marketplace that HIV may be a longer-term franchise than some think.”
T2Bacteria panel shows promise for rapidly and accurately diagnosing ESKAPE pathogens
In 2018, the T2Bacteria Panel, produced by T2Biosystems (MA, USA) was cleared by the FDA to identify sepsis-causing bacteria directly from whole blood without the wait for blood culture. In new research, published in Annals of Internal Medicine, the panel was tested in 1427 patient at 11 US hospitals.
The researchers compared blood culture results with those obtained using the T2Bacteria Panel, demonstrating the T2Bacteria Panel accurately identified or excluded bloodstream infections caused by five common ESKAPE pathogens in about 4– 8 hours versus about 24–72 hours and 5 days, respectively, for blood cultures. According to the researchers, these findings suggest that using the T2Bacteria Panel could shorten the time to appropriate antibiotic treatment in patients.
China approves GSK’s shingles vaccine, Shingrix
GlaxoSmithKline (Brentford, UK) has announced that China’s National Medicinal Product Administration has approved its shingles vaccine, Shingrix, for prevention of shingles in adults aged 50 or older. The vaccine’s introduction into China will be phased, beginning next year.
The approval is based on data from Phase III trials ZOE-50 and ZOE-70, which demonstrated that Shingrix was more than 90% effective against shingles in the age group studied.
Thomas Breuer, chief medical officer of GlaxoSmithKline’s vaccines unit, commented: “We welcome the Chinese government’s progress to enable faster entry of new products into China and we look forward to working with the relevant agencies to bring the benefits of this vaccine to local communities.”
Merck receives Breakthrough Therapy designation from FDA for pneumococcal vaccine V114
Merck (NJ, USA), known as MSD outside of the United States and Canada, has announced that the company’s investigational 15-valent pneumococcal conjugate vaccine, V114, has received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age.
The Breakthrough Therapy Designation is designed to expedite the development and review of drugs intended for serious or life-threatening conditions and the decision for V114 was informed by the immunogenicity data from two Phase II studies – Study 005 and Study 008. V114 is also under development for the prevention of IPD in adults and both pediatric and adult indications are currently under Phase III trials.
Nicholas Kartsonis, Head of vaccine and infectious diseases clinical research at Merck Research Laboratories, commented: “We are pleased with the data on V114 compiled to date, and we look forward to working closely with the FDA on the subsequent development of this investigational vaccine. The goal of our program in pediatric patients remains focused on providing additional serotype coverage versus currently available vaccines, while at the same time maintaining a strong immune response across all serotypes in the vaccine.”
Hackensack Meridian Health receives $33.3 million from NIH to develop new antibiotics
Hackensack Meridian Health, New Jersey’s (NJ, USA) largest and most comprehensive health network, has announced the receipt of a $33.3 million grant from the National institutes of Health (NIH, MD, USA) to develop new antibiotics for drug-resistant infections.
The grant will be used to establish a Center of Excellence for Translational Research, a public-private partnership that brings together prominent scientists from the Center for Discovery and Innovation, as well as other institutions and industry.
“We are proud to receive this record grant which will produce new therapies to tackle drug-resistant infections and save lives,” commented CEO of Hackensack Meridian Health Robert Garrett. “This is exactly why we created our new Center for Discovery and Innovation – to deliver tomorrow’s breakthroughs today.”
Polyphor halts enrollment in Phase III studies of antibiotic murepavadin after high rate of kidney injury
Polyphor (Allschwil, Switzerland) have temporarily halted enrollment in Phase III trials investigating their lead antibiotic, murepavadin, for the treatment of patients with nosocomial pneumonia. The decision followed higher than expected acute kidney injuries in the murepavadin arm of the PRISM-MDR trial; kidney alteration incidences were observed in 56% of patients, as opposed to the estimates incidence of 20–40% that was expected.
Frank Weber, Polyphor Director and Chief Medical and Development Officer, commented: “While pro-actively halting the Phase III trials for murepavadin is disappointing, patient safety is of utmost importance to Polyphor. We are trying to better understand the reasons for these events and exploring ideas on how to tackle them for the future, as we remain convinced that murepavadin could still represent a valuable drug to help patients fighting pseudomonas infections.”
Dynavax Technologies (CA, USA) has announced that as apart of a restructuring plan it will focus on its hepatitis B vaccine, Heplisav-B and explore strategic alternatives for its immuno-oncology portfolio.
The company also plans to cut approximately 37% of its US workforce. Heplisav-B gained FDA approval in 2017 for the prevention of infection caused by all known subtypes of hepatitis B virus in adults
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