Novartis' heart failure medicine LCZ696 granted accelerated assessment by CHMP in Europe[1] - Seite 2
LCZ696 is an ARNI (Angiotensin Receptor Neprilysin Inhibitor) and has a unique mode of action which is thought to reduce the strain on the failing heart. It harnesses the body's natural defenses against heart failure, simultaneously acting to enhance the levels of natriuretic and other endogenous vasoactive peptides, while also inhibiting the renin-angiotensin-aldosterone system (RAAS).
Heart failure is a debilitating and life-threatening disease in which the heart cannot pump enough blood around the body. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life.
It is a significant and growing public health concern with a high unmet need for new treatments. Every year, the total cost of heart failure (HFrEF and HFpEF) to the worldwide economy is $108 billion[7], and hospitalizations comprise 60-70% of treatment costs[8],[9].
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Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "accelerated assessment," "could," "investigational," "expedited review procedure," "expected,"
"committed," "will," "may," "expects," "planned," "Fast Track," "being investigated," "can," or similar terms, or by express or implied discussions regarding potential marketing approvals for
LCZ696, or the timing of any such approvals, or regarding potential future revenues from LCZ696. You should not place undue reliance on these statements. Such forward-looking statements are based
on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee
that LCZ696 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that LCZ696 will be commercially successful in the future. In particular,
management's expectations regarding LCZ696 could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual
property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other
risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.