Lundbeck Inc. Release: FDA Approves Changes To The SABRIL (vigabatrin) REMS Program

DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck today announced that the U.S. Food and Drug Administration (FDA) approved a modified Risk Evaluation and Mitigation Strategy (REMS) for Sabril^® (vigabatrin). Streamlining of the REMS process is not due to any change in the risk of Sabril-induced permanent vision loss. The Sabril REMS program, formerly known as SHARE, has been changed after the FDA determined that some of the program’s requirements are no longer necessary to ensure that the benefits of Sabril outweigh the risks. The new Sabril REMS program will be effective on July 21, 2016.

“When Sabril was approved by the FDA in 2009, Lundbeck worked with the FDA to launch the therapy along with an extensive REMS program to monitor the risk of vision loss”

Sabril is indicated as adjunctive therapy for patients 10 years of age and older with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first line agent for CPS. Sabril is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.

“When Sabril was approved by the FDA in 2009, Lundbeck worked with the FDA to launch the therapy along with an extensive REMS program to monitor the risk of vision loss,” said Alina M Fernández, MD, MPH, MBA, VP, Global Pharmacovigilance-US, Lundbeck. “The modifications announced today are the result of many meetings between the FDA and Lundbeck, healthcare professionals and the patient community. We're pleased with the reduced burden associated with prescribing Sabril.”

About the Modified REMS

The Sabril REMS Program (formerly known as SHARE) will administer the REMS process, and Sabril will continue to only be available through select specialty and inpatient pharmacies. Lundbeck will continue to provide support through SHAREPlus, including dedicated customer support, benefits investigation, a free starter prescription while benefits investigation is underway, co-pay assistance and a patient assistance program for patients who qualify.

The modified REMS program will alleviate some of the burden associated with prescribing Sabril, as physicians will have fewer forms to submit. Previously, physicians were required to document completion of five forms in order to prescribe Sabril. Under the new modified Sabril REMS Program, only two forms must be completed and submitted to the Sabril REMS Program. An optional Sabril Prescription Form is available for physicians who choose to submit a prescription through Lundbeck’s SHAREPlus Program. Alternatively, physicians may submit a prescription directly to a pharmacy certified to dispense SABRIL.

Completing the optional Sabril Prescription Form on www.Sabril.net will allow healthcare providers and patients/caregivers access to Lundbeck’s SHAREPlus support program, which includes: dedicated customer support, benefits investigation, a starter prescription while benefits investigation is underway, co-pay assistance, and a patient assistance program for those who qualify.

Healthcare providers must complete an enrollment form to become certified with the new Sabril REMS Program and begin prescribing Sabril for their patients. Currently enrolled prescribers have 90 days from approval of REMS modification, starting June 21, 2016, within which to complete their new enrollment in order to maintain their ability to prescribe Sabril. Currently enrolled patients do not need to re-enroll or complete any new forms in order to continue receiving Sabril as prescribed by their healthcare provider.

Healthcare providers will no longer need to complete the treatment initiation form, treatment maintenance form or ophthalmologic assessment form as part of the Sabril REMS program (formerly known as SHARE). Although the treatment maintenance form has been removed, a benefit risk assessment still needs to be performed as outlined in the prescribing information. Although faxing the ophthalmologic assessment form has been removed as a REMS requirement, vision testing is still recommended, as outlined in the Sabril prescribing information: within 4 weeks of treatment initiation, every 3 months during therapy, and 3-6 months after treatment discontinuation. The risk of vision loss with Sabril still remains the same, and changes to the REMS process are not due to any change in the risk of Sabril-induced permanent vision loss. Physicians and patients should report any adverse event suggestive of vision loss to the Sabril REMS Program at 1-888-457-4273.

Since the ophthalmologic assessment form will no longer need to be sent to the Sabril REMS Program, drug shipment will no longer be contingent upon completion of this testing and reminder letters will no longer be sent to physicians and patients.

More details on the Sabril REMS Program and the optional Sabril Prescription Form will be available in the coming weeks.

Use

SABRIL (vigabatrin) is a prescription medicine used with other treatments in adults and children 10 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss. SABRIL should not be the first medicine used to treat CPS.

SABRIL (vigabatrin) is a prescription medicine used in babies, 1 month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

Important Safety Information

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All people who take SABRIL:

• You are at risk for vision loss with any amount of SABRIL.

• Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it.

• It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped.

• Because SABRIL might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the SABRIL Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.
• SABRIL can damage the vision of anyone who takes it. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.
• Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting SABRIL; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
• It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting SABRIL, and at least every 3 months during treatment until SABRIL is stopped. It is also recommended that vision be tested about 3 to 6 months after SABRIL is stopped. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
• Vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow SABRIL to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
• If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss.
• Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL. It is not known if these changes are harmful.
• Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and actions in some people. Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.
• Do not stop SABRIL without first talking to a healthcare provider. Stopping SABRIL suddenly can cause seizures that will not stop.
• SABRIL can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because SABRIL causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
• Before starting SABRIL, tell your doctor about all of your (or your child’s) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to SABRIL, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illness. Tell your doctor about all the medicines you (or your child) take.
• If you are breastfeeding or plan to breastfeed, SABRIL can pass into breast milk and may harm your baby. If you are pregnant or plan to become pregnant, it is not known if SABRIL will harm your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.
• The most common side effects of SABRIL in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled. The most common side effects of SABRIL in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.
• The most common side effects of SABRIL in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and irritability.
• Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. These are not all of the possible side effects of SABRIL. For more information, ask your healthcare provider or pharmacist.

For more information, please see SABRIL Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use; go to www.sabril.net, or call toll-free 1-888-457-4273.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

SABRIL is a registered trademark of Lundbeck

About Lundbeck

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of research within neuroscience. The key areas of focus are Alzheimer’s disease, depression, Parkinson’s disease and psychosis.

An estimated 700 million people worldwide are living with brain disease and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain disease – we call this Progress in Mind.

Our approximately 5,500 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 14.6 billion in 2015 (EUR 3.9 billion; USD 6.4 billion).

In the U.S., Lundbeck employs nearly 1,000 people focused solely on accelerating therapies for brain diseases. With a special commitment to the lives of patients, families and caregivers, Lundbeck US actively engages in hundreds of initiatives each year that support our patient communities. To learn more, visit us at www.LundbeckUS.com.

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