Novartis announced today that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) has concluded the
risk-benefit review of Rasilez and combination products containing aliskiren
and confirmed it remains positive in the European Union (EU) for the treatment
of essential hypertension. In addition, the CHMP has requested an update to the
product information of Rasilez® (aliskiren) and combination products containing
aliskiren available in the EU.
The CHMP has requested that Rasilez and combination products containing
aliskiren are contraindicated in patients who are receiving an angiotensin converting
enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) who also have
diabetes and/or moderate to severe renal impairment (GFR < 60 ml/min/1.73
m2). In addition, the CHMP has requested the inclusion of a warning against the
use of Rasilez and combination products containing aliskiren in patients who
are also taking an ACE inhibitor or an ARB.
"This decision comes after extensive interactions between Novartis and
the CHMP. Patient safety continues to be the highest priority for Novartis, and
we are working closely with the CHMP, EMA and other health authorities
worldwide to continue to provide Rasilez and combination products containing
aliskiren to the most appropriate patient population who would benefit,"
said David Epstein, Division Head of Novartis Pharmaceuticals.
The product information for Rasilez and combination products containing
aliskiren in the EU are being updated. Novartis will also write to physicians
in the EU informing them of these changes to the product information.
The CHMP review of Rasilez risk-benefit began in December 2011 following
the Novartis decision to halt the ALTITUDE study after the Data Monitoring
Committee reviewed preliminary interim analyses and concluded that study
patients were unlikely to benefit from aliskiren and there was a higher
incidence of adverse events related to non-fatal stroke, renal complications,
hyperkalaemia and hypotension in this high-risk population.
Starting in December 2011, Novartis wrote to physicians worldwide
recommending that patients with type 2 diabetes should not be treated with
aliskiren, or combination products containing aliskiren, if they are also
receiving an ACE inhibitor or ARB. This recommendation remains in place in
countries outside of the EU as Novartis continues discussions with the
respective health authorities, including the US FDA. As a precautionary
measure, in December 2011 Novartis stopped promotion of Rasilez/Tekturna and
combination products containing aliskiren in combination with an ACE inhibitor
or ARB.
Based on the revised product information, physicians in the EU will now be
advised that patients who have diabetes and/or moderate to severe renal
impairment, who are also taking Rasilez and an ACE inhibitor or an ARB, should
receive alternate treatment under a physician's supervision. In other patients
taking Rasilez or combination products containing aliskiren in combination with
an ACE inhibitor or an ARB, the balance of benefits and risks of continuing
treatment should be considered carefully.
Any patients using Rasilez or combination products containing aliskiren who
may have questions about their medication should consult their healthcare
provider. For more information visit
http://www.novartis.com/newsroom/rasilez-tekturna-information-center/index.shtml.
The label changes in the EU will be applied to all approved aliskiren-based
products. These products include Rasilez®, Sprimeo®, Riprazo®, Rasilez HCT®,
Sprimeo HCT®, Riprazo HCT®, Rasilamlo®, and Rasitrio®.
About Aliskiren
Aliskiren was approved in the EU and US in 2007 under the brand names Rasilez and Tekturna respectively, for the treatment of hypertension either as monotherapy or in combination with other medications. It is available in 63 countries. These products remain available for appropriate patients.
Rasilez-based products available in the EU include:
- Rasilez/ Sprimeo/ Riprazo
- Rasilez HCT/ Sprimeo HCT/ Riprazo HCT, a single-pill combination of Rasilez and hydrochlorothiazide (HCT)
- Rasilamlo, a single-pill combination of Rasilez and amlodipine
- Rasitrio, a triple combination of Rasilez, amlodipine and hydrochlorothiazide (HCT)
About ALTITUDE
ALTITUDE was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of aliskiren to reduce the risk of cardiovascular and renal events in this patient population.
ALTITUDE was the first randomized, double-blind, placebo-controlled study
to investigate aliskiren for more than one year in a specific population of
patients with type 2 diabetes and renal impairment. These patients are known to
be at high risk of cardiovascular and renal events. In the study, aliskiren was
given in addition to optimal cardiovascular treatment including an angiotensin
converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).