Esperion passes approval landmark for cholesterol drug
The FDA has approved a new therapy designed for adjunctive use in patients who cannot reach their cholesterol-reduction goals with statin treatment alone. Esperion Therapeutics' Nexletol was approved as a monotherapy late last week and as a fixed-dose combination with ezetimibe on Wednesday.
With US approvals secured, focus will now shift onto Esperion's ability to commercialise Nexletol and the company's long promised goal to pitch its drug as a cheaper and more convenient alternative to the PCSK9 inhibitors. To this end, Esperion's pricing strategy looks aggressive, though Nexletol has yet to demonstrate positive data in a large cardiovascular outcomes study, with results expected in 2023 at the earliest.
Safety concerns are raised for new AMD therapy
Novartis delivered a record haul of six novel drug approvals in the US market last year, claiming that five of these products have the potential to generate peak global sales of at least $1 billion.
However, prescriber uptake of one of these franchises – the wet age-related macular degeneration (AMD) treatment Beovu, which was approved by the FDA in October – could now slow after safety concerns were raised by the American Society of Retina Specialists (ASRS), warned analysts.
In a communication issued to members, ASRS noted that among approximately 46,000 Beovu injections administered to patients in the US to date, 14 cases of vasculitis have been associated with the drug, including 11 reported cases of occlusive retinal vasculitis.
Novartis says it stands behind the safety and efficacy of Beovu. In addition to an internal assessment, it has engaged an external safety review committee to evaluate post-marketing cases of vasculitis, the company confirmed.
Bio-pharma rallies as coronavirus concerns grow
Against a backdrop of the coronavirus crisis developing into a truly global issue this week as more cases were identified in Europe and the Middle East in particular, there was further mobilisation from the pharmaceutical and biotechnology sectors in a bid to accelerate efforts to find effective treatments and a vaccine.
Most notably, three pivotal-stage studies evaluating Gilead Sciences' broad-spectrum antiviral remdesivir in patients infected with COVID-19 were initiated. One of the studies is being run in the US by the National Institute of Allergy and Infectious Diseases with the other two enrolling patients primarily from countries in Asia.
The director of the FDA's Centre for Biologics Evaluation and Research, Peter Marks, was quoted this week as suggesting that new drugs to treat patients who are infected with COVID-19 will emerge more rapidly than a vaccine. Marks said that the suggestion a vaccine could be ready to move into pivotal-stage studies in three months' time is likely too optimistic.
The Chinese pharmaceutical company Clover Biopharmaceuticals announced this week that GlaxoSmithKline will provide its pandemic adjuvant system as part of efforts to develop a vaccine against COVID-19 infections. Clover plans to evaluate the adjuvant system in preclinical studies of its trimeric SARS-CoV-2 spike protein-based coronavirus vaccine candidate dubbed S-Trimer.
Earlier this month, GlaxoSmithKline agreed to make its pandemic vaccine adjuvant platform technology available as part of a collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to speed the development of an effective immunisation against COVID-19.
NGM fires up expectations for FGF agonists in NASH
2020 could be a pivotal year for the industry's aspirations to grow a new market for therapies to treat non-alcoholic steatohepatitis (NASH) with Intercept Pharmaceuticals' experimental drug obeticholic acid due to be reviewed, and potentially approved, by the FDA later this year.
In the meantime, encouraging Phase II data released by NGM Bio this week will fuel optimism for the potential role that FGF agonists could play in the treatment of NASH. Results show that the drug aldafermin (formerly known as NGM282) was able to significantly reduce both fibrosis and NASH resolution after 24 weeks. The trial's primary endpoint measuring liver fat content was also met, with aldafermin associated with a 39% reduction in MRI-PDFF versus 13% for placebo.
NGM emphasised that aldafermin is the only NASH candidate to have demonstrated efficacy against a composite endpoint evaluating both reduction in fibrosis scores and NASH resolution, suggesting this is more impressive given that the study was not powered for statistical significance on these secondary measures.
M&A rumours bring Iovance’s TIL-based therapies into focus
Iovance Biotherapeutics was a big gainer this week, on the back of reports that it has attracted takeover interest.
Any interest in Iovance will have been spurred by its potential in extending the use of cell therapy to certain solid tumours; its most advanced treatments are being evaluated in melanoma and cervical cancer patients.
Question marks over Iovance's ability to commercialise the technology it is developing remain, however. The company's pipeline of experimental tumour infiltrating lymphocyte (TIL) therapies is built on a model of extracting these from a patient's tumour and expanding them with an IL-2 graft before reinfusion.
A number of academic centres have already used this process to positive effect at treating melanoma, a tumour type which is well suited to this approach given its immunogenicity.
Iovance is expected to release registration-supporting data for TILs to treat melanoma and cervical cancer later this year and also plans to complete regulatory filings with the FDA. Earlier-stage data in head and neck cancer will also be closely watched to see if the approach is replicable across less immunogenic tumour types.
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