EMA supports use of Novartis' Gilenya MS drug treatment
The continued use of a drug treatment for multiple sclerosis (MS), Novartis AG’s Gilenya, has been supported by the European Medicines Agency (EMA).
However, the EMA has said the drug, which is otherwise known as fingolimod, needs to come with stronger warnings about its heart risks.
Novartis has said it will work with the EMA to implement the suggested changes and updates, which will give further guidance to healthcare professionals about potential treatments using Gilenya.
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Doctors will be advised not to prescribe Gilenya to patients with heart conditions such as cardiovascular and cerebrovascular disease.
They will also be advised against giving the MS treatment to those on heart medication.
Additionally, the EMA has said that in the European Union, all MS patients starting treatment with Gilenya should have an electrocardiogram (ECG) and a blood pressure measurement prior to the first dose of the medicine and after the six-hour first-dose monitoring period.
Blood pressure and heart rate should be measured every hour during this period and continuous ECG monitoring is recommended for a minimum of six hours following the first dose.
Commenting on the EMA’s approval for the continued use of Gilenya, David Epstein, the Division Head of Novartis Pharmaceuticals, said: “We believe that Gilenya is a valuable treatment option for many patients with relapsing remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug which also supports our continued belief of the blockbuster potential of Gilenya.
“MS is a devastating chronic disease that affects more than 2.1 million people worldwide, and patients need effective treatment options.”
Industry analysts anticipate that Gilenya will prove to be a blockbuster drug from Novartis and some forecasts suggest by 2015 it could have reached sales of $1.7 billion.
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Dubai's new smart neuro spinal hospital: need to know
We take a look at Dubai's new smart hospital.
What: The Neuro Spinal Hospital and Radiosurgery Centre is a new hospital featuring state-of-the-art technology for spinal, neurosurgical, neurological, orthopaedic, radiosurgery and cancer treatments. The 700 million AED hospital, (equivalent to £138 million), has 114 beds, smart patient rooms, and green spaces for patient rehabilitation, and is four times the capacity of its former premises in Jumeirah. It is also the UAE’s first hospital to have surgical robots.
Where: The hospital is located in the Dubai Science Park. Founded in 2005, Dubai Science Park is home to more than 350 companies from multinational corporations in life sciences, biotechnology and research; over 4,000 people work here each day.
Who: The UAE's Neuro Spinal Hospital and Radiosurgery Centre was first established in Jumeirah in 2002 by Dr. Abdul Karim Msaddi, as the first as the first "super-specialty" neuroscience hospital.
Why: With advanced diagnosis and robotics, the hospital will provide care across neuroscience, spine, orthopaedics and oncology for people residing in the UAE, as well as international patients.
Prof. Abdul Karim Msaddi, Chairman and Medical Director of the hospital, said: “We are proud to bring world-class healthcare services to Dubai and believe our next-generation hospital will be a game-changer for the emirate’s and the region’s medical industry.
"It will not only significantly increase the availability of specialist neuroscience and radiosurgery treatments and provide better patient care but help attract and develop local and international talent. Investing in the new centre represents our continued faith in the resilience of the region’s economy, as well as a testament to our ongoing drive towards healthcare innovation in the UAE.”