Novartis heart drug enters UK’s early access scheme

By Selina McKee

Novartis’ investigational heart drug LCZ696 (sacubitril/valsartan) has become the first non-cancer drug to get a foothold in the UK’s Early Access to Medicines Scheme.

The drug, an angiotensin receptor neprilysin inhibitor, has completed the first of a two-stage evaluation process, picking up Promising Innovative Medicine (PIM) status as a potential treatment for patients with heart failure (HF) with reduced ejection fraction.

The move comes on the back of data from the PARADIGM-HF trial, which showed that LCZ696 significantly improved patient outcomes compared to the current gold standard treatment, including a reduction in cardiovascular deaths, Novartis said.

If quality, safety and efficacy data are found to be sufficient to support a positive benefit/risk balance and added clinical value, the Medicines and Healthcare products Regulatory Agency will issue an EAMS Scientific Opinion for the drug, at which point it can be used to treat patients, well ahead of when it would become available through normal regulatory channels.

Medicines in EAMS will typically be commissioned by NHS England through its specialised commissioning arrangements, and drugmakers are expected to provide their medicines free of charge to the NHS while prescribed under the scheme.


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