FDA Round-Up: New Options for COPD, Melanoma, Crohn's Disease

Spiriva Respimat: COPD

The FDA has approved Spiriva Respimat (tiotropium bromide) for use in patients with chronic obstructive pulmonary disease. ¹

The drug—already available as an inhaled powder—will now be available as an inhaled spray. The new version is intended for once daily use for the long-term maintenance of COPD.

Spiriva Respimat was approved based on the results of 7 clinical trials comparing results of more than 5700 patients against more than 5700 using Spiriva HandiHaler.

Side effects include sore throat, cough, dry mouth, and sinus infection.
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Humira: Pediatric Crohn’s Disease

Humira (Adalimumab) has received its 8^th indication in the United States, adding reducing the signs and symptoms of pediatric Crohn’s disease in patients 6-years and older after other treatments have failed.²

The drug works by inhibiting tumor necrosis factor-alpha and is self-administered with the proper training via injection. 

In a study of 192 patients (age 6 to 17), researchers found that Humira was able to induce and maintain remission of symptoms in patients and had a safety profile similar to that seen in adults with the disease.

Keytruda: Melanoma

The FDA has approved the Keytruda (pembrolizumab) injection for the treatment of patients with unresectable or metastic melanoma.³

Keytruda works by blocking the cellular pathway (PD-1), which in turn improves immune response against tumors.

Researchers administered 2 mg/kg or 10 mg/kg of Keytruda to 173 participants in a study of the drug’s efficacy. They observed a 24% response rate in 2 mg/kg and similar response rates in the 10 mg/kg group.

The most common side effects of Keytruda include fatigue, cough, nausea, pruritus, and diarrhea.

Movantik: Opioid-Induced Constipation

The FDA has approved Movantik (naloxegol) for the treatment of opioid-induced constipation in adult patients with chronic pain.⁴

A peripherally acting opioid receptor antagonist, Movantik is able to decrease the constipating effects of opioids.

The drug proved effective in 2 clinical trials of 1352 patients with opioid-induced constipation. They were assigned either 12.5 mg or 25 mg of the drug or placebo to be taken once daily for 12 weeks.

In the first trial, 44% of participants who received 25 mg of Movantik and 41% of those taking 12.5 mg experienced positive results, compared with 29% of those taking placebo. The second trial showed similar results.

Side effects include abdominal pain, diarrhea, headache, and excessive stomach gas.

—Michael Potts

References:

1. Boehringer-Ingelheim. Asthma: new indication for Spiriva (tiotropium) Respimat* in the EU may offer millions of adults a significant advance in asthma care [press release]. www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/08_september_2014_asthma.html. Accessed September 26, 2014.

2. Abbvie. AbbVie's HUMIRA (adalimumab) receives US FDA approval for the treatment of pediatric patients with moderately to severely active crohn's disease [press release]. http://abbvie.mediaroom.com. Accessed September 26, 2014.

3. OPTUMRx. Keytruda (pembrolizumab)—new orphan drug approval. [press release]. www.optumrx.com. Accessed September 26, 2014.

4. FDA. FDA approves Movantik for opioid-induced constipation [press release]. www.fda.gov. Accessed September 25, 2014.