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FDA approves Breo Ellipta for COPD

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for chronic obstructive pulmonary disease, the agency said Friday.

The FDA announced the approval of Breo Ellipta (fluticasone furoate and vilanterol), a once-per-day inhaler made by GlaxoSmithKline and Theravance for long-term treatment of COPD, which includes chronic bronchitis and emphysema.

"COPD is a serious disease that makes breathing difficult," FDA Office of Drug Evaluation II director Curtis Rosebraugh said. "The availability of new, long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD."

 

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FDA approves Novartis’ Ilaris for rare childhood arthritis

BY Alaric DeArment

EAST HANOVER, N.J. — The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

Novartis announced the approval of Ilaris (canakinumab) for active systemic juvenile idiopathic arthritis in patients ages 2 years and older. The company said the drug was the first once-per-month drug for injection under the skin to be approved for SJIA. The disease is a rare and disabling form of arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years and continue into adulthood, according to studies. The drug is also approved for treating rare, lifelong and debilitating genetic disorders known as cryopyrin-associated periodic syndromes.

"In the United States, this approval marks the second Ilaris indication for patients living with rare, autoinflammatory conditions," Novartis Pharmaceuticals global head of development Timothy Wright said.

 

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Denovo Biomarkers, ALS-ETF to explore personalized medicine in amyotrophic lateral sclerosis

BY Alaric DeArment

SAN DIEGO — A biotech company and a nonprofit organization are looking into new ways to treat patients with the devastating degenerative disorder commonly known as Lou Gehrig’s disease.

The ALS Emergency Treatment Fund and Denovo Biomarkers announced Friday a deal to explore the use of personalized medicine in treating patients with the disease, known medically as amyotrophic lateral sclerosis. The two said the approach could accelerate drug development in ALS and other life-threatening disorders.

"This exciting relationship with Denovo Biomarkers may accelerate the development of drugs for ALS and may help us provide useful information for patients and physicians," ALS-ETF managing director Jess Rabourn said.

 

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