Novartis and AZ drugs move through UK’s early access scheme

Novartis is the latest drugmaker to get approval for one of its products under the UK’s fast-track scheme, getting the go-ahead from the Medicines and Healthcare products Regulatory Agency (MHRA) for its new heart failure therapy LCZ696.

Meanwhile, AstraZeneca (AZ) has also moved a step closer to that objective for its lung cancer therapy AZD2921 after the UK regulator awarded it Promising Innovative Medicine (PIM) status, the first stage in the Early Access to Medicines Scheme (EAMS).

LCZ696, which is approved in the US as Entresto, is the first non-cancer drug to navigate its way through the EAMS pathway, which is designed to make innovative new drugs available to patients before they get regulatory approval and a cost-effectiveness ruling from NICE.

The drug is used to treat adult patients with symptomatic heart failure and reduced left ventricle ejection fraction (LVEF) – in other words when the heart cannot pump blood adequately and the percentage of blood leaving the heart each time it contracts is lower than normal.

The MHRA said that Novartis’ drug warranted inclusion in the EAMS because “despite different available treatment options, patients with heart failure, especially those with reduced ejection fraction, have a poor prognosis and admissions to hospital are common.”

LCZ696 combines Novartis’ long-established angiotensin II receptor antagonist valsartan with sacubitril, a first-in-class neprilysin inhibitor.

The MHRA does note, however, that experience of the drug’s use in patients who have not previously been treated with ACE inhibitors or angiotensin II receptor is limited. It advises caution when starting therapy in these patients as there may be a higher risk of side effects.

LCZ696 was also the first product to be granted an accelerated review by the European Medicines Agency (EMA), which is currently reviewing the application and could deliver a verdict before the end of the year.

The EAMS verdict is yet another indication that LCZ696/Entresto is on course to transform heart failure treatment, and become a blockbuster product for Novartis in the process. Some analysts have predicted peak sales of up to $10 billion a year, buoyed by the huge number of people with heart failure worldwide and a hefty lead over other neprilysin inhibitors in development.

Lung cancer therapy

Meanwhile, PIM status for AZD9291 is an exciting development for patients with non-small cell lung cancer (NSCLC) in the UK and comes after AZ reported positive survival data on the drug earlier this year. AZD9291 is a new generation epidermal growth factor receptor (EGFR) inhibitor that is a follow-up to the company’s NSCLC therapy Iressa (gefitinib).

PIM is designed to give an early signal that the medicine may be a possible choice for the EAMS scheme and might be able to help people who have no other treatment options. It has been granted for the drug as a treatment for locally-advanced or metastatic EGFR-positive patients with secondary T790M mutations.

AZ recently filed for approval of the drug with US and European regulators and has predicted the drug could be a blockbuster with sales of $3 billion at peak.

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