FDA remains firmly in COVID-19 spotlight
The FDA has been unable to shake off any controversy surrounding its recent response to the COVID-19 pandemic, which looks poised to be a major talking point in the lead-up to November's election.
Its recent controversial decision to issue an emergency-use authorisation (EUA) for convalescent plasma to treat hospitalised patients with COVID-19 has come in for further scrutiny after an expert panel convened by the US National Institutes of Health (NIH) concluded that "there are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19."
Furthermore, FDA Commissioner Stephen Hahn has indicated that he would be willing to consider granting emergency authorisation for an investigational COVID-19 vaccine before clinical trials have been completed if the benefits outweigh the risks. "It is up to the [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application," Hahn said, adding that "if they do that before the end of Phase III, we may find that appropriate. We may find that inappropriate, we will make a determination."
His comments have raised concerns the FDA could be pressured to rush through approval of a vaccine by the Trump administration in the build-up to the election. Hahn insisted "this is going to be a science, medicine, data decision. This is not going to be a political decision."
Corticosteroids confirmed as best current therapeutic option for virus
Results of a meta-analysis published Wednesday in JAMA suggest that the use of systemic corticosteroids in critically ill patients with COVID-19 is associated with lower 28-day all-cause mortality compared to usual care or placebo. Study author Jonathan Sterne noted that the benefit was seen regardless of age, sex or how long patients had been ill for. Based on the latest evidence, the World Health Organization issued new treatment guidance strongly recommending steroids to treat severely and critically ill COVID-19 patients.
"Steroids are a cheap and readily available medication, and our analysis has confirmed that they are effective in reducing deaths amongst the people most severely affected by COVID-19," Sterne remarked. The latest findings follow results from the RECOVERY study released in June, which found that low-dose dexamethasone reduced the risk of death by up to one third in hospitalised patients with severe respiratory complications of COVID-19.
Elsewhere, Sanofi said Tuesday that a Phase III trial investigating Kevzara (sarilumab) in severely or critically ill patients hospitalised with COVID-19 failed to meet its primary endpoint and key secondary goal. The company and partner Regeneron Pharmaceuticals noted that they "do not anticipate conducting further clinical studies" of the IL-6 receptor antibody for COVID-19.
Nestlé takes aim at food allergy market
Nestlé has strengthened its food allergy portfolio by agreeing to acquire Aimmune Therapeutics for $2.6 billion, gaining the latter's peanut allergy treatment Palforzia.
Palforzia was authorised by the FDA in January for individuals aged four through 17 years, making it the first, and so far only, approved treatment to help reduce the frequency and severity of allergic reactions to peanuts in children.
Nestlé Health Science holds an approximate 25.6% equity ownership stake in Aimmune, having initially taken a stake in the company in 2016. Vontobel analyst Jean-Philippe Bertschy described the deal as "another milestone" for Nestlé Health Science after it acquired nutritional health products company Atrium Innovations in 2017 for $2.3 billion.
Gilead's IO spending spree continues
Gilead Sciences announced Tuesday the licensing of exclusive rights to Jounce Therapeutics' JTX-1811 programme, an anti-CCR8 monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. Under the agreement, Gilead will make an upfront payment of $85 million to Jounce, as well as an equity investment of $35 million.
Earlier this year, Gilead acquired Forty Seven for approximately $4.9 billion, further boosting the company's presence in immuno-oncology, whilst it has also take equity stakes in Pionyr Immunotherapeutics and Tizona Therapeutics.
Full data from the Phase III EMPOROR-Reduced study, presented at last weekend's virtual annual meeting of the European Society of Cardiology (ESC), show that in adults with heart failure with reduced ejection fraction, with and without diabetes, Boehringer Ingelheim and Eli Lilly's Jardiance was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalisation due to heart failure.
These data look broadly comparable to earlier results for another SGLT2 inhibitor, AstraZeneca's Farxiga – see ViewPoints: Game on in HF for SGLT2 class.
Forthcoming analysis – KOL Views: Where do SGLT2s fit in the intra-, inter-class pecking order in heart failure?
Elsewhere at ESC, detailed findings from the Phase III DAPA-CKD trial showed that adding Farxiga to standard care reduced the composite measure of deteriorating renal function, or risk of death from cardiovascular or kidney disease, by 39% versus placebo in patients with chronic kidney disease (CKD). AstraZeneca noted that the results were consistent in CKD patients both with and without type 2 diabetes.
Also at the conference, Amarin presented new data showing that its eicosapentaenoic acid drug Vascepa is the first and only agent studied on top of statins to have demonstrated coronary plaque regression in hypertriglyceridaemic patients. However, Amarin's commercial outlook for Vascepa appears to have been significantly weakened by earlier than expected loss of US patent exclusivity.
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