FDA Approvals

Benlysta Approved for Children With Lupus

MONDAY, April 29, 2019 -- The intravenous drug Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat children with lupus, a chronic disease that triggers inflammation and damages tissues and organs throughout the body.

Approved for adults since 2011, Benlysta is the first lupus treatment in the United States approved for children, the agency said in a news release.

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Device Helps Doctors Select Lungs for Transplant

MONDAY, April 29, 2019 -- The Xvivo Perfusion System has been approved by the U.S. Food and Drug Administration to help doctors determine whether lungs are suitable for transplant, the agency said in a news release.

The device can temporarily ventilate, oxygenate and pump preservation solution through the lungs, allowing a transplant team to conduct a more thorough assessment of lung function.

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Balversa Approved for Advanced Bladder Cancer

MONDAY, April 15, 2019 -- Balversa (rdafitinib) has been approved by the U.S. Food and Drug Administration to treat adults with advanced or spreading bladder cancer caused by a genetic defect called FGFR3 or FGFR2, the agency said in a news release.

"We're in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient's specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. Today's approval represents the first personalized treatment targeting susceptible FGFR genetic alternations for patients with metastatic bladder cancer," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

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Evenity Approved for Osteoporotic Women

TUESDAY, April 9, 2019 -- Evenity (romosozumab) injection has been approved by the U.S. Food and Drug Administration to treat osteoporosis in postmenopausal women at high risk of breaking a bone, the agency said Tuesday in a news release.

More than 10 million people in the U.S. have osteoporosis, making their thinning bones more likely to fracture, the FDA said. Most are women who have gone through menopause.

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Ibrance Approval Expanded to Include Men With Breast Cancer

THURSDAY, April 4, 2019 -- U.S. Food and Drug Administration approval of Ibrance (palbociclib) capsules has been widened to include men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or spreading (metastatic) breast cancer, the agency said Thursday in a news release.

"Today we are expanding the indication for Ibrance to include male patients based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

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Mavenclad Approved for Multiple Sclerosis

MONDAY, April 1, 2019 -- Mavenclad (cladribine) tablets have been approved by the U.S. Food and Drug Administration to treat relapsing multiple sclerosis (MS) in adults.

An agency news release said the drug is recommended for people who have had an inadequate response to, or are unable to tolerate, another medication approved for MS. Mavenclad is not sanctioned for a form of MS called clinically isolated syndrome.

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Cimzia Approved for Inflammatory Arthritis

FRIDAY, March 29, 2019 -- Cimzia (certolizumab pegol) injection has been approved by the U.S. Food and Drug Administration as the first sanctioned treatment for adults with non-radiographic axial spondyloarthritis (nr-axSpA), a type of arthritis.

Nr-axSpA causes inflammation in the spine, There is no visible damage seen on x-rays, so it is referred to as non-radiographic, the FDA explained in a news release.

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Jatenzo Approved for Men With Low Testosterone

THURSDAY, March 28, 2019 -- Jatenzo (testosterone undecanoate) has been approved by the U.S. Food and Drug Administration to treat men with low testosterone, medically called hypogonadism.

The approval covers men with low levels of the male hormone due to specific medical conditions, including genetic disorders such as Klinefelter syndrome or tumors that have damaged the pituitary gland, the agency said in a news release.

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Mayzent Approved for Relapsing MS

WEDNESDAY, March 27, 2019 -- Mayzent (siponimod) pills have been approved by the U.S. Food and Drug Administration for adults with relapsing multiple sclerosis (MS).

"Multiple sclerosis can have a profound impact on a person's life," said Dr. Billy Dunn, director of the agency's Division of Neurology Products.

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New Heart Failure Device Is Approved

THURSDAY, March 21, 2019 -- The Optimizer Smart System has been approved by the U.S. Food and Drug Administration for people with chronic, moderate-to-severe heart failure who are not candidates for other heart failure remedies.

"Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do," said Dr. Bram Zuckerman, director of the agency's Division of Cardiovascular Devices.

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