Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis - Seite 3

About AIN457 (secukinumab) and interleukin-17A (IL-17A)
AIN457 (secukinumab) is a first-in-class human monoclonal antibody (mAb), being investigated for diseases that affect the immune system[11]-[13]. The first IL-17A inhibitor to be reviewed by the FDA for moderate-to-severe plaque psoriasis, secukinumab has been shown to selectively bind to and neutralize IL-17A, inhibiting the release of pro-inflammatory cytokines (messenger proteins)[11]-[16]. Detailed results from Phase III studies for arthritic conditions (psoriatic arthritis and ankylosing spondylitis) will be presented later this year.

IL-17A is a key messenger protein involved in the development of plaque psoriasis, and is found in high concentrations in psoriasis skin plaques[11]-[16]. Research shows IL-17A plays an important role in driving the body's immune response in disorders such as moderate-to-severe plaque psoriasis and certain arthritic conditions and may represent a new target for investigational therapies[11]-[16].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "recommends," "anticipated," "support," "recommendation," "look forward," "expected," "being investigated," "will," "may," "investigational," or by express or implied discussions regarding potential marketing approvals for AIN457 or regarding potential future revenues from AIN457. 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 AIN457 will be approved for sale in any market where it has been submitted, or that AIN457 will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that AIN457 will achieve any particular levels of revenue in the future. In particular, management's expectations regarding AIN457 could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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.