FDA Accepts Filing of BETACONNECT for Relapsing-Remitting Multiple Sclerosis Patients Taking BETASERON (interferon beta-1b)
WHIPPANY, N.J., April 22, 2015 /PRNewswire/ — Bayer is pleased to announce today that the U.S. Food and Drug Administration (FDA) has accepted the filing for Bayer’s supplemental Biologics License Application (sBLA) for BETACONNECT TM (proposed name), another delivery option for BETASERON® (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis.
“This filing underscores Bayer’s continued, longstanding commitment to meeting the needs of patients taking BETASERON to treat their relapsing forms of MS,” said Dario Mirski, M.D., Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “We have proudly supported the MS community for more than 20 years.”
BETASERON® (interferon beta-1b) is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.
Important Safety Information for BETASERON (interferon beta-1b)
Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.
*Proposed name BETACONNECT™
BETASERON can cause serious side effects, including:
Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily or bleeding problems. Your healthcare provider will do blood tests to check for these problems while you take BETASERON.
Serious Allergic Reactions. Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.
Depression or Suicidal Thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.
Other possible serious side effects with BETASERON include:
Heart Problems. BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.
Injection Site Problems. Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area of the skin that is sore, reddened, infected or has other problems.
Flu-like Symptoms. BETASERON can cause flu-like symptoms including fever, chills, tiredness, sweating, muscle aches when you first start to use it. These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms.
Seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, or to a combination of both. If you have a seizure after taking BETASERON call your healthcare provider right away.
Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily.
Risk to Pregnancy:
BETASERON can harm your unborn baby. BETASERON may cause you to lose your baby (miscarry). If you become pregnant while taking BETASERON call your healthcare provider right away. You and your healthcare provider should decide if you should continue to take BETASERON.
Most Common Side Effects:
The most common side effects of BETASERON include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, weakness. These are not all the possible side effects of BETASERON.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.
For full prescribing information visit http://labeling.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
© 2015 Bayer HealthCare Pharmaceuticals Inc.
BAYER, Betaseron and the Bayer Cross are registered trademarks of Bayer.
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Source: PR Newswire Health
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