US FDA warns of serious liver injury linked to hepatitis C drugs: September’s industry headlines


Take a look at this month’s industry headlines including FDA warnings over hepatitis C drugs in patients with liver injury, a new infectious diseases strategy for the UK and priority review for Merck’s Ebola vaccine.

Interim results for mRNA therapies against CMV and chikungunya

Moderna (MA, USA) has released interim results from two Phase I trials assessing its experimental mRNA therapies for chikungunya and cytomegalovirus (CMV). One study is assessing mRNA-1647, a vaccine combining six mRNAs, in 169 healthy adults. Currently this program is set to advance to mid-stage development as results are showing that in seronegative individuals neutralizing antibody titers were three- to five-times higher than seropositive baseline titers.

The second study, assessing mRNA-1944, demonstrated that this therapy in healthy adults led to detectable levels of CHKV-24 antibody in all participants. However, Moderna did note some adverse events. Chief Medical Officer Tal Zaks commented: “[These] data represent a significant scientific breakthrough: this study shows for the first time the ability to generate therapeutic levels of a complex protein in humans through systemic administration of an mRNA, essentially instructing the body to make its own medicines.”

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US FDA warns of serious liver injury linked to hepatitis C drugs from AbbVie, Merck & Co. and Gilead

The US FDA has issued a drug safety communication identifying 63 cases of serious liver injury in patients using AbbVie’s Mavyret (glecaprevir/pibrentasvir) (IL, USA), Merck & Co’s Zepatier (elbasvir/grazoprevir)(NJ, USA) and Gilead Sciences’ Vosevi (sofosbuvir/velpatasvir/voxilaprevir) (CA, USA) to treat hepatitis C.

The FDA reports that many of these cases occurred in patients with symptoms of moderate-to-severe liver impairment who “should not have been treated with these medicines.” The cases of liver decompensation generally occurred within 4 weeks of first treatment, although some ended in liver failure and death. The FDA cautioned that Mavyret and Zepatier should not be prescribed to patients with a history of hepatic decompensation, while Vosevi is not recommended for individuals with a history of hepatic decompensation unless its benefits are deemed to outweigh the risks of liver injury, liver failure or death.

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Public Health England launches new infectious disease strategy

Public Health England (PHE; London, UK) have announced a new 5-year strategy hoping to strengthen the agency’s ability to detect, prevent and respond to infectious disease outbreaks. The strategy is built around six core functions: prevent and protect, detect and control, prepare and respond, build and apply, advise and collaborate, generate and share – that PHE hope will enable it to reach its priorities, including reducing vaccine-preventable diseases, tackling antimicrobial resistance and combating rising sexually transmitted infections.

Chris Whitty, incoming Chief Medical Officer, commented: “Despite our arsenal of vaccines and antimicrobials, infectious disease remains a real threat to public health. We are constantly faced with new threats, and anti-microbial resistance is growing. This new strategy will enable us to detect and prevent new threats as they arise, keeping us safe from potentially devastating consequences.”

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Genentech announces full Phase III results for one-dose XOFLUZATM

Genentech (CA, USA) has announced the full results from Phase III trials MINISTONE-2 and BLOCKSTONE at the OPTIONS X congress (28 August – 1 September, Singapore). Highlights include the MINISTONE-2 study, which is assessing XOFLUZA vs. oseltamivir in children aged 1–12, meeting its primary endpoint and being demonstrated as comparable to oseltamivir. In addition, the BLOCKSTONE trial, a Phase III post-exposure study evaluating a single dose of XOFLUZA (vs. placebo) as a preventive treatment for household members who are living with someone with a confirmed flu infection, showed that significantly reduced the risk of people developing the flu by 86% compared with the placebo.

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Discover more about MINISTONE-2 >

GSK license Ionis’ hepatitis B program

GSK (Brentford, UK) has exercised its option to license Ionis’ (CA, USA) antisense medicines for patients with chronic hepatitis B virus infection following positive Phase II results. The data will be presented at a future conference, but under the agreement Ionis will be eligible to receive license fees and milestone payments up to US $262 million, as well as tiered royalties on net sales of any commercialized products. Chief Operating Officer at Ionis, Brett Monia, stated: “We believe GSK’s development and commercialization expertise in infectious diseases makes them the ideal partner to help address this high unmet need.”

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Merck & Co’s experimental Ebola vaccine granted FDA priority review

Merck & Co have announced that their experimental Ebola vaccine, V920, has been granted priority review by the FDA, with a decision expected in March 2020.

In 2016 results from a Phase III trial carried out in Guinea demonstrated that V920 was highly protective against Ebola, in addition the vaccine is currently being used in the Democratic Republic of Congo Ebola outbreak. Merck Research Laboratories Vice President Paula Annunziato commented: “A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply can be produced over time to support global public health preparedness and health security objectives.”

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Want to discover more about the outbreak in the Democratic Republic of Congo? Read about the first year >

Cidara Therapeutics and Mundipharma partner to develop and commercialize antifungal, rezafungin

Cidara Therapeutics (CA, USA) and Mundipharm (Cambridge, UK) have announced a strategic partnership with the aim of developing and commercializing rezaungin – a novel, once-weekly echinocandin antifungal.

The partnership follows Cidara’s recent announcement of positive Phase II trial results.  The agreement states that in exchange for granting Mundipharm commercialization rights to rezafungin in the USA and JAPAN Cidara will reieve an upfront payment of US $30 million and Mundipharm will make an equity investment of US $9 million.

Jeffrey Stein, Chief Executive officer of Cidara, commented: “Mundipharma is particularly well positioned globally with established hospital and hematology/oncology business units to fully leverage the commercial potential of rezafungin. Through this partnership, both companies fully commit to advancing rezafungin and helping to save the lives of patients who are highly vulnerable to these deadly infections.”

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Noscendo gains CE certification for diagnostic platform DISQVER® and carries out piloting

Noscendo GmbH (Duisburg, Germany) has announced that its diagnostic platform DISQVER® has been awarded CE certification. Noscendo’s platform detects bacteria, fungi, DNA viruses and parasites in the patient’s bloodstream using next-generation sequencing and proprietary algorithms to assess the corresponding pathogen relevance.

Following certification, the company has also carried out pilot testing with eight maximum care hospitals in Germany assessing and demonstrating the benefits of DISQVER® with regards to the identification of primary pathogens across multiple pathogen classes.

Managing Director of Noscendo GmbH, Philip Stevens, commented: “We will continue to work at full speed on the development of our diagnostic platform with regards to automated pathogen detection of bloodstream-associated infections, in order to define a new gold standard in intensive care.”

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FDA approves expanded indication for Merck’s DELSTRIGOTM and PIFELTROTM HIV treatments

The FDA has approved expanded indications for DELSTRIGO and PIFELTRO as treatments for use in appropriate adults living with HIV-1 who are virologically suppressed on a stable regimen and with no history of treatment failure.

The approval is based on findings from the Phase III DRIVE-SHIFT trial evaluating a shift to DELSTRIGO in 670 participants. George Hanna, Vice President and Therapeutic Area Head of Infectious Diseases, commented: “Today’s approvals provide doravirine treatment options for people living with HIV-1 who are virally suppressed, reflecting Merck’s continued commitment to research and development of HIV treatments.”

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FDA releases draft guidance on medically important antibiotic use in animals

The FDA has released new draft guidance aiming to restrict the use of medically important antibiotics in livestock and companion animals. The new guidance will bring the antibiotics that can be bought over-the-counter under the oversight of licensed veterinarians. This builds on a previous policy (#213) that limited important antibiotics being used in animal feed and water but did not cover a handful of products, primarily injectable antibiotics.

The FDA is proposing a 2-year implementation period that would begin once this guidance has been finalized.

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