The Lemon Fool

AstraZeneca's Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.1-4

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2021.

China's National Medical Products Administration (NMPA) has updated the label for AstraZeneca's Forxiga (dapagliflozin) to include data from the DECLARE-TIMI 58 Phase III trial.

DECLARE-TIMI 58 demonstrated that Forxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or cardiovascular (CV) death, versus placebo, in adults with type-2 diabetes (T2D) and established CV disease or multiple CV risk factors. The trial confirmed the well-established safety profile of Forxiga.1

AstraZeneca and Oxford University jointly developed COVID-19 vaccine-induced immune response in older adults in their phase 2 trial, the British drug makers confirmed Thursday.

AstraZeneca's Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.

Bouleversee wrote:Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.

Bouleversee wrote:Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.

An experimental coronavirus vaccine developed by AstraZeneca and the University of Oxford protected against COVID-19 in two late-stage, placebo-controlled trials of roughly 23,000 participants in the U.K. and Brazil, the development partners said Monday.

An interim analysis after 131 volunteers developed COVID-19 found that, on average, vaccination was 70% effective in preventing the disease. A lower-dose regimen, with a half-dose given first followed by a full dose one month later, was 90% effective, while two full doses appeared 62%
effective.

The preliminary results are encouraging and suggest a third experimental coronavirus vaccine works, after positive data from the team of Pfizer and BioNTech, and Moderna earlier this month. AstraZeneca and Oxford's shot uses a different technology than the other two — a signal other vaccines approaches could be effective, too — and is viewed as easier to distribute around the world.

Yet the differing results between dosing regimens are likely to raise questions about how AstraZeneca and Oxford's vaccine triggers the immune system. And the data will be compared to the higher-than-expected efficacy shown by Pfizer and BioNTech and by Moderna, both of which said their vaccines were roughly 95% effective in preventing COVID-19.

Bouleversee wrote:Thanks, Ian. Of interest but incomprehensible.

monabri wrote:Of course, the message will be it will not sell in the USA ..so what? The AZN vaccine will be sold around the World. It has the reputable names of AZN and Oxford University attached to it, it is practical regarding storage requirements and it is cheaper than Pfizer's offering.

Bouleversee wrote:Why on earth did this news sent the s.p. down around 2%. So far as I could understand from R4 discussions, with 1.5 doses it is just as effective as the others and has the advantage of not needing to be kept at such low temperatures. I know that at this stage they are doing it on a not-for-profit basis but we have known that all along and there must be some benefit in future years.