FDA courts controversy with Trump's shadow looming large
On Monday, the FDA controversially issued an emergency-use authorisation (EUA) for convalescent plasma as a potential treatment for COVID-19 in hospitalised patients having previously concluded there was not sufficient clinical evidence to do so.
Days earlier, President Donald Trump had criticised the administration by suggesting (with no disclosed evidence) that some senior staff were seeking to delay approval and access to potential COVID-19 therapeutics in a bid to harm his bid for re-election in November.
The EUA was subsequently announced at a White House press conference with much fanfare, but is widely expected to have a moderate impact at best on the utilisation of convalescent plasma to treat COVID-19 (due to supply constraints stemming from a limited number of potential donors).
The FDA attracted further scrutiny resulting from the misleading claim by President Trump and Commissioner Stephen Hahn that use of convalescent plasma had been shown to reduce mortality in COVID-19 patients by 35%, despite a lack of clear evidence to substantiate this.
These events have raised concerns that the FDA could be pressured into issuing a EUA for an investigational COVID-19 vaccine ahead of November's election. A public advisory committee meeting convened to discuss a number of vaccine candidates will take place on October 22, less than two weeks before Americans vote.
Latest vaccine developments
Development programmes for the most advanced COVID-19 vaccines continue to evolve.
Late last week, BioNTech and Pfizer published new data supporting their decision to select the vaccine candidate BNT162b2 for late-stage testing on the strength of a superior side-effect profile.
On Wednesday, Moderna published interim Phase I data showing that its investigational vaccine mRNA-1273 was safe and generated an immune response in people aged 55 and over. These new findings build on interim data published in the NEJM last month demonstrating that a two-dose vaccination schedule of mRNA-1273, administered via intramuscular injections given 28 days apart, induced anti–SARS-CoV-2 immune responses, including antibody and T-cell responses, in all 45 healthy younger volunteers aged 18 to 55 years.
Moderna noted for the first time that mRNA-1273 will be shipped and stored at minus 20 degrees, but can be kept in a refrigerator for seven days. This could provide a logistical, and ultimately competitive, advantage over BioNTech and Pfizer’s mRNA vaccine candidate which requires distribution and storage at minus 70 degrees and can only be refrigerated for 24 hours (or kept at room temperature for just 2 hours). Another front-runner in this race, the investigational adenovirus vaccine AZD1222 being developed by AstraZeneca and Oxford University, can be refrigerated for up to 12 months.
Moderna also confirmed that as of Tuesday, 15,239 participants had been enrolled in its Phase III study for mRNA-1273, with a target to recruit 30,000 subjects. Pfizer and BioNTech are similarly placed (approximately halfway towards a 30,000 target) with AstraZeneca and the University of Oxford having recruited approximately 11,500 subjects across three studies in Brazil, South Africa and the UK.
Latest survey shows 90% of physicians now interacting with at least some patients face-to-face
Our latest COVID-19 survey (of 1107 physicians across 10 major global markets) shows that the number of face-to-face interactions between physicians and patients continued to increase in July versus June and May.
Survey data show that over 90% of respondents are now consulting with patients face-to-face, compared to a rate of 70% in May. Concurrently, there has been a decline in the number of physicians engaging with patients by telephone or video call over this period.
The average number of patients physicians met with face-to-face increased in July versus the prior two months. In the office/clinic setting, respondents said they had interacted in-person with an average of 42 patients over the previous week, up from an average of 28 in May and 38 in June. Interaction rates with patients in hospitals continue to grow more slowly, with physicians meeting an average of just one more patient in this setting in July versus June (14 compared to 13).
Key new drug approvals for GSK, Novartis
GlaxoSmithKline said Wednesday that the European Commission has granted conditional approval for the antibody-drug conjugate Blenrep (belantamab mafodotin) for use as monotherapy to treat multiple myeloma in adults. Specifically, the anti-BCMA drug, which was cleared by the FDA last month, is indicated for patients who have received four or more prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Late last week, Novartis confirmed FDA approval of Kesimpta (ofatumumab) injection for subcutaneous use to treat adults with relapsing forms of multiple sclerosis (RMS), including relapsing-remitting MS, active secondary progressive MS and clinically isolated syndrome. The approval provides Novartis the opportunity to take on Roche's anti-CD20 MS therapy Ocrevus in the US market.
Foundation scores key cancer diagnostic approval
Foundation Medicine has secured FDA approval for the FoundationOne Liquid CDx, a pan-tumour liquid biopsy test that analyses 324 cancer-related genes for alterations, enabling it to be used as a companion diagnostic to identify patients who may benefit from treatment with targeted therapies. Last month, the FDA approved Guardant Health's Guardant360 CDx as the first liquid biopsy diagnostic for comprehensive genomic mutation profiling in tumours.
Foundation Medicine is seeking additional companion diagnostic claims for the FoundationOne Liquid CDx, which, at launch, can be used to determine patient suitability for Clovis Oncology's PARP inhibitor Rubraca and the EGFR inhibitors Iressa, Tagrisso (both AstraZeneca) and Tarceva (Roche).
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