Simponi Approved for Ulcerative Colitis

Blocks process that contributes to abnormal inflammation

By Scott Roberts

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

The drug is designed to block tumor necrosis factor, which has a key role in causing abnormal inflammation and immune system responses, the FDA said Wednesday in a news release.

The drug has already been approved to treat psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis, the agency said.

Ulcerative colitis, affecting some 620,000 Americans, causes chronic inflammation and ulcers in the inner lining of the large intestine. Common symptoms include abdominal discomfort, gastrointestinal bleeding and diarrhea.

Simponi was clinically evaluated in two studies involving more than 800 people. The most common side effects reported were upper respiratory infection and redness at the injection site. People treated with the drug are at greater-than-average risk of contracting several types of infection, lymphoma, heart failure, nervous system disorders and allergic reactions, the FDA said.

The drug is marketed by Janssen Biotech Inc., based in Horsham, Pa.

View the original article here

Simponi Approved for Ulcerative Colitis

WEDNESDAY, May 15 (HealthDay News) -- Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

The drug is designed to block tumor necrosis factor, which has a key role in causing abnormal inflammation and immune system responses, the FDA said Wednesday in a news release.

The drug has already been approved to treat psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis, the agency said.

Ulcerative colitis, affecting some 620,000 Americans, causes chronic inflammation and ulcers in the inner lining of the large intestine. Common symptoms include abdominal discomfort, gastrointestinal bleeding and diarrhea.

Simponi was clinically evaluated in two studies involving more than 800 people. The most common side effects reported were upper respiratory infection and redness at the injection site. People treated with the drug are at greater-than-average risk of contracting several types of infection, lymphoma, heart failure, nervous system disorders and allergic reactions, the FDA said.

The drug is marketed by Janssen Ortho Biotech Inc., based in Horsham, Pa.

-- Scott Roberts
Copyright © 2013 HealthDay. All rights reserved.

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Breo Ellipta Approved for COPD

Respiratory disease is the third-leading cause of death in U.S.

By Scott Roberts

HealthDay Reporter

FRIDAY, May 10 (HealthDay News) -- Americans with chronic obstructive pulmonary disease (COPD) may have new help in their quest to breathe better, with the approval of Breo Ellipta on Friday.

This combination drug has been approved by the Food and Drug Administration to treat COPD, which includes chronic bronchitis or emphysema.

COPD is the third-leading cause of death in the U.S. behind heart disease and cancer, with typical symptoms including chronic cough, chest tightness and excess phlegm. Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) is designed to reduce lung inflammation and to relax muscles that impact the lung airways, the FDA said Friday in a news release.

The drug's safety and effectiveness were clinically evaluated in some 7,700 people with COPD. Common side effects included nasal inflammation, upper respiratory infection and headache.

Less common but more serious side effects could include bone fracture and pneumonia, the agency said.

The drug's label will carry a warning of increased risk for asthma-related death. The medication has not been tested in, or approved for, people with asthma, the FDA warned.

Breo Ellipta was developed by North Carolina-based GlaxoSmithKline and San Francisco-based Theravance.

View the original article here

Simponi Approved for Ulcerative Colitis

Blocks process that contributes to abnormal inflammation

By Scott Roberts

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

The drug is designed to block tumor necrosis factor, which has a key role in causing abnormal inflammation and immune system responses, the FDA said Wednesday in a news release.

The drug has already been approved to treat psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis, the agency said.

Ulcerative colitis, affecting some 620,000 Americans, causes chronic inflammation and ulcers in the inner lining of the large intestine. Common symptoms include abdominal discomfort, gastrointestinal bleeding and diarrhea.

Simponi was clinically evaluated in two studies involving more than 800 people. The most common side effects reported were upper respiratory infection and redness at the injection site. People treated with the drug are at greater-than-average risk of contracting several types of infection, lymphoma, heart failure, nervous system disorders and allergic reactions, the FDA said.

The drug is marketed by Janssen Biotech Inc., based in Horsham, Pa.

View the original article here