FDA Approvals

First Drug Approved for Rare Condition That Inflames Blood Vessels

TUESDAY, Dec. 12, 2017 -- Nucala (mepolizumab) has been approved by the U.S. Food and Drug Administration as the first remedy to treat adults with eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that leads to inflammation of the blood vessels.

Other symptoms of the condition, formerly called Churg-Stress syndrome, include asthma and an overabundance of an infection-fighting white blood cell called an eosinophil. The inflamed blood vessels may affect the lungs, intestines, skin, heart and nervous system.

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New Diabetes Drug Gets FDA OK Under 'Abbreviated' Pathway

MONDAY, Dec. 11, 2017 -- Admelog (insulin lispro), a short-acting form of insulin, has been approved by the U.S. Food and Drug Administration to treat people with either type of diabetes, for patients aged three years and older.

It's the first drug approved as a "follow-up" product based on an abbreviated new process dubbed 505(b)(2), the agency said Monday in a news release.

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Ozempic Approved for Type 2 Diabetes

WEDNESDAY, Dec. 6, 2017 -- Ozempic (semaglutide) has been approved by the U.S. Food and Drug Administration as a weekly injection to treat type 2 diabetes in adults.

More than 28 million people in the United States have type 2 diabetes, which occurs when the body can no longer produce the sugar-regulating hormone insulin, or the body can't use insulin properly.

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FDA Approves 'Biosimilar' Drug Ogivri for Breast, Stomach Cancers

FRIDAY, Dec. 1, 2017 -- Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as the nation's first biosimilar drug to treat certain breast and stomach cancers, the agency said Friday in a news release.

The maker of a biosimilar, derived from a living organism, must demonstrate that the new product is "highly similar" to an already approved medication, and that it has no clinically significant difference in terms of its potency, safety and purity, the FDA said.

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Once-Monthly Injection Approved for Opioid Addiction

FRIDAY, Dec. 1, 2017 -- Sublocade, a once-monthly injection of buprenorphine to treat opioid use disorder, has been approved by the U.S. Food and Drug Administration.

Opioid abuse is diagnosed when a person's pattern of opioid use leads to "significant impairment or distress and includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose," or opioids are taken in far higher-than-recommended doses, the agency said in a news release.

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New Hemophilia Treatment Stems Bleeding Episodes

THURSDAY, Nov. 16, 2017 -- Hemlibra (emicizumab-kxwh) has been approved by the U.S. Food and Drug Administration to prevent or reduce the number of bleeding episodes among certain people with hemophilia A.

The injected drug was approved for patients with antibodies called Factor VIII inhibitors. People with hemophilia A are missing a gene that produces Factor VIII, a blood-clotting protein.

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Mepsevii Approved for Rare Enzyme Disorder

WEDNESDAY, Nov. 15, 2017 -- Mepsevii (vestronidase alfa-vjbk) has been approved by the U.S. Food and Drug Administration to treat a rare, genetic disorder called mucopolysaccharidosis type VII, sometimes called Sly syndrome.

Affecting fewer than 150 people worldwide, the extremely rare disorder typically causes various skeletal abnormalities that worsen with age, including short stature. Life expectancy and symptoms and vary widely, but also may include heart valve problems, enlarged liver and narrowed respiratory airways, the agency said Wednesday in a news release.

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'Digital Pill' Tells Doctor When Patient Takes It

TUESDAY, Nov. 14, 2017 -- The first drug designed to alert a doctor when a patient takes the medication has been approved by the U.S. Food and Drug Administration.

Abilify MyCite (aripiprazole with sensor) has an embedded sensor that sends a message to a wearable patch that the medication's been taken. This allows the patient and doctor to track the medication's use via smartphone.

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Zelboraf Approved for Rare Blood Cancer

MONDAY, Nov. 6, 2017 -- Zelboraf (vemurafenib) has been approved by the U.S. Food and Drug Administration as the first drug to treat Erdheim-Chester Disease, a rare but deadly blood cancer. The approval covers patients who have a genetic mutation called BRAF V600.

Erdheim-Chester Disease is a slow-growing cancer that originates in bone marrow, causing a spike in a type of white blood cell called a histiocyte. This can spur tumors that develop in the heart, lung, brain and elsewhere, the FDA said Monday in a news release. The cancer only affects about 700 people worldwide, about half of whom have the BRAF V600 mutation.

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Calquence Approved for Mantle Cell Lymphoma

TUESDAY, Oct. 31, 2017 -- Calquence (acalabrutinib) has been approved by the U.S. Food and Drug Administration to treat adults with mantle cell lymphoma.

Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system. Though it represents only 3 percent to 10 percent of non-Hodgkin cases in the United States, the cancer usually has spread by the time it's detected, the FDA said in a news release on Tuesday.

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