– The Nobelpharma Connect patient program will be launched for the first time –
– Nobelpharma is a Presenting Sponsor of the TSC 2022 Global Conference –
BETHESDA, MD., July 25, 2022 /PRNewswire/ — Nobelpharma America, LLC, a pharmaceutical and medical device company headquartered in Bethesda, Marylandwill debut HYFTOR™ (sirolimus topical gel) 0.2%, the first-ever U.S. FDA-approved topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC) for patients 6 years of age and older at the TSC 2022 World Conference at the Hilton Anatole hotel in Dallas, TXof July 28-31, 2022.
“We anticipate that we will be able to have in-depth discussions with healthcare professionals and people with TSC who are interested in learning more about HYFTOR™,” said Yoshiki Kida, President and CEO of Nobelpharma America. “We will also have the opportunity to explain the services that Nobelpharma will offer to the community through our new patient access program, Nobelpharma Connect.”
Nobelpharma Connect is a patient hub where patients can learn more about eligibility and enrollment for access programs, including the assistance program, copayment program, and other support services.
Nobelpharma will start supplying HYFTOR™ via a network of specialized pharmacies in August. For any inquiries during the interim period, please do not hesitate to contact Nobelpharma at [email protected].
TSC 2022 Global Conference Presenting Sponsor
Nobelpharma continues its support for people with TSC, their families and healthcare providers as the presenting sponsor of the TSC 2022 Global Conference.
The 2022 TSC Global Conference, co-hosted by the TSC Alliance and Tuberous Sclerosis Complex International, will bring together up to 1,000 participants from around the world, including families and individuals with TSC, caregivers, healthcare professionals health and researchers. The programs will share information about diagnosis, treatment and research and explore solutions to the daily challenges of people with TSC experience.
“Nobelpharma is committed to advancing the scientific understanding of TSC and providing new options for individuals and families affected by this disease,” said Kida. “As we introduce HYFTOR™we look forward to strengthening our relationships within the patient community, maintaining a dialogue and listening to their experiences to help shape the future of research and treatment.”
About Tuberous Sclerosis Complex (TSC)
TSC is a rare genetic disorder that affects approximately one in every 6,000 live births. It is estimated that nearly one million people worldwide have TSC, including approximately 50,000 in United States. TSC causes noncancerous tumors, or hamartomas, to form in vital organs, including the skin. TSC can also cause facial angiofibromas, which are pink or red bumps usually located on the cheeks, nose, and chin, which can cause bleeding, itching, redness, and significant disfigurement without treatment. Many people with TSC also have autism, epilepsy, and other neuropsychiatric disorders.
About HYFTOR™ (sirolimus topical gel) 0.2%
[i].
HYFTOR™ (sirolimus topical gel) 0.2% is the first and only clear topical drug approved by the FDA to treat TSC-associated facial angiofibroma in adults and children 6 years of age and older. Gel application should be limited to areas of angiofibroma involvement and application sites should not be obstructed. In clinical studies, HYFTOR™ has been shown to improve the size and redness of facial angiofibromas at 12 weeks. HYFTOR™ is contraindicated in patients with a history of hypersensitivity to sirolimus or any other component of the gel. Please see important safety information for HYFTOR™ below. Additional information is available in the full prescribing information for HYFTOR™ (sirolimus topical gel) 0.2%. www.HYFTORPI.com
About facial angiofibroma associated with tuberous sclerosis complex
Tuberous sclerosis complex (TSC) is a rare autosomal dominant genetic disorder that causes benign tumors to grow throughout the body. These tumors can grow on the skin and vital organs, including the brain, kidneys, lungs and heart, and can lead to behavioral and neurological manifestations such as autism, intellectual disability and epilepsy. TSC-associated facial angiofibromas are facial skin lesions caused by aberrant activation of the mechanistic target rapamycin (mTOR) pathway. These are pinkish or reddish bumps that are usually located on the cheeks, nose, and chin. Left untreated, they can cause significant disfigurement, bleeding, pruritus, and erythema.
About Nobelpharma America
Nobelpharma America, LLC (NPA) is focused on the commercialization of pharmaceutical products and medical devices for patients with limited treatment options. The company is committed to meeting critical patient needs by developing treatments for diseases that are often overlooked due to a small patient population. NPA is located at 4520 East-West Highway, Suite 400, Bethesda, MD 20814. For more information, visit nobelpharma-us.com. NPA is a wholly owned subsidiary of Nobelpharma Co., Ltd., TokyoJapan.
Indication
HYFTOR™ (sirolimus topical gel) 0.2% is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and children 6 years of age and older. HYFTOR™ (sirolimus topical gel) 0.2% is not indicated for children under 6 years of age.
IMPORTANT SAFETY INFORMATION
Important: HYFTOR™ is for use only on the skin (topical use). Do not use HYFTOR™ in the mouth, eyes or vagina.
Do not use HYFTOR™ if you are allergic to sirolimus or any of the other ingredients in HYFTOR.
Before using HYFTOR™tell your healthcare provider about all your medical conditions, including if you:
- have a skin infection at the treatment site
- have high levels of cholesterol or triglycerides (fats or lipids) in your blood
- must receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with HYFTOR™. Vaccines may be less effective during treatment with HYFTOR.
- are pregnant or plan to become pregnant. HYFTOR™ may harm your unborn baby. You must not become pregnant while taking HYFTOR™.
- Women who could become pregnant should use effective contraception before starting treatment with HYFTOR, during treatment and for 12 weeks after your last dose of HYFTOR.™. Talk to your health care provider about the types of birth control you can use during this time.
- are breastfeeding or planning to breastfeed. It is not known if HYFTOR™ passes into your breast milk. You should not breast-feed during treatment with HYFTOR™.
Tell your healthcare professional about all medications you are taking, including prescription and over-the-counter medications, vitamins and herbal supplements.
What should I avoid when using HYFTOR™?
Limit your exposure to sunlight and artificial light, such as tanning beds and ultraviolet light therapy, during treatment with HYFTOR™. Wear clothes that cover your skin if you must go out. Talk to your healthcare provider about other ways to protect your skin from the sun.
What are the possible side effects of HYFTOR™?
HYFTOR™ can cause serious side effects, including:
- Allergic reactions. Serious allergic reactions have occurred in people who have taken sirolimus by mouth. Stop using HYFTOR™ and see a doctor straight away if you have any of these symptoms: swelling of the face, eyes or mouth, difficulty in breathing or wheezing, tightness in your throat, chest pain or tightness, feeling of dizziness or fainting, rash or peeling skin.
- infections. Serious infections, including infections that can occur when your immune system is weakened, have occurred in people who have taken sirolimus by mouth. Some people have developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML) which can sometimes lead to death. Stop using HYFTOR™ and call your healthcare provider right away if you have any symptoms of infection, including fever or chills.
- Risk of cancer. Lymphoma and other cancers, especially skin cancers, have occurred in people who have taken sirolimus by mouth. Talk to your healthcare provider about your cancer risk if you use HYFTOR™.
- Increased levels of cholesterol and triglycerides (fats or lipids) in the blood have occurred in people who have taken sirolimus by mouth. Your health care provider will treat you for high lipid levels, if necessary.
- Lung or breathing problems. Lung or breathing problems, including problems that sometimes caused death, have happened in people who took sirolimus by mouth. Stop using HYFTOR™ and see a doctor right away if you have symptoms such as shortness of breath, new or worsening cough, or chest pain.
The most common side effects of HYFTOR™ to understand dry skin, application site irritation, itching, acne, acne-like rash, eye redness, skin bleeding and skin irritation.
HYFTOR™ can cause fertility problems in both men and women, which may affect your ability to have children. Speak to your health care provider if this concerns you.
These are not all the possible side effects of HYFTOR™. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
Please see patient information www.HYFTORPI.com for more information on security.
[i] See full prescribing information for HYFTOR™ (sirolimus topical gel) 0.2%. www.HYFTORPI.com
SOURCE Nobelpharma America
