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Weekly Drug News Round Up - September 16, 2015

Spiriva Respimat Wins FDA Nod for Asthma Maintenance

The approval of Spiriva Respimat establishes a new class for asthma prevention Read More…

Today, the U.S. Food and Drug Administration (FDA) approved Spiriva (tiotropium) Respimat for long-term, once-daily asthma maintenance in people ages 12 and older. When asthma symptoms persist despite taking a daily maintenance treatment such as an inhaled corticosteroid, adding inhaled Spiriva Respimat may help people breathe better and reduce asthma attacks. For asthma, the FDA approved a once-daily dose of 2.5 micrograms (µg) (delivered in 2 puffs of 1.25 µg each). Spiriva Respimat, a bronchodilator known as a long-acting muscarinic antagonist (LAMA), is also approved to prevent bronchospasm in chronic obstructive pulmonary disease (COPD).

Humira Wins Approval As First Drug for Hidradenitis Suppurativa

Orphan drug designation provides Humira seven years of market exclusivity for HS Read More...

Hidradenitis suppurativa is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts. This past week, the U.S. Food and Drug Administration (FDA) approved Abbvie’s Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). In the PIONEER I and PIONEER II studies of 633 people with moderate to severe HS, Humira resulted in more reductions in total abscesses and inflammatory nodules than patients given placebo. No new safety risks were identified in these trials.

FDA Approves Nuwiq for Hemophilia A

Hemophilia A impacts the lives of up to 16,000 individuals in the U.S. Read More...

A lack of antihemophilic factor VIII, a protein that helps blood to clot, is the cause of hemophilia A. The U.S. Food and Drug Administration (FDA) has approved Nuwiq, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children with Hemophilia A. Nuwiq is used to control active bleeding; to prevent the frequency of bleeding episodes; and in bleeding related to surgical procedures. In Nuwiq clinical trials, the annualized bleeding rate was reduced 96% for adults and 93% for children. Frequently occurring side effects (0.7%) in 135 patients included paresthesia, headache, injection site inflammation or pain, back pain, vertigo, and dry mouth.

FDA: Labeling and REMS Program Enhanced for Clozapine

Prescribers and pharmacies will be required to be certified in the Clozapine REMS Program starting in October Read More...

Clozapine, an antipsychotic medication used for schizophrenia, is associated with neutropenia, a dangerously low number of white blood cells that help to fight off infections. This week, the U.S. Food and Drug Administration (FDA) has changed the requirements for treating patients with clozapine. FDA has clarified the prescribing information for monitoring and management of neutropenia. Also, FDA has approved a new, shared risk evaluation and mitigation strategy (REMS) called the Clozapine REMS Program. The Clozapine REMS Program replaces the six existing clozapine registries maintained by individual clozapine manufacturers. The revised prescribing information and the Clozapine REMS Program aims to improve monitoring and management of patients with severe neutropenia.

USPSTF: Low-Dose Aspirin Should Target Those in Their Fifties

For the first time it’s noted that aspirin for heart disease also appears to decrease risk of colon cancer Read More...

In 2009, the U.S. Preventive Services Task Force (USPSTF) stated that low-dose aspirin could help men 45 to 79 and women 55 to 79 prevent heart disease. This week, based on new evidence, the task force concluded there's insufficient evidence to recommend low-dose aspirin in people younger than 50, or 70 and older. The latest recommendations are based on the AHA/ACC cardiovascular risk calculator. People in their 50s who have a 10 percent or greater risk of developing heart disease over the next 10 years and are not at increased risk for bleeding may benefit from 81 milligrams (mg) of aspirin taken every day, the task force concluded.