9 FDA Drug Actions in February for Techs to Know

Learn about the new drugs and expanded indications approved by the FDA in February 2016.

1. Aczone

On February 25, 2016, the FDA approved Allergan’s dapsone 7.5% gel (Aczone) for patients aged 12 years and older.

Indicated for the treatment of both inflammatory and noninflammatory acne, Aczone 7.5% gel is the first formulation of the acne drug to provide patients with a once-a-day application option.

In clinical trials, patients treated with Aczone 7.5% gel experienced significant improvement in acne after 12 weeks. The drug was also found to be well-tolerated.

The most common adverse event associated with the use of Aczone is dryness at the application site.

Allergan plans to launch Aczone 7.5% gel in the United States in May 2016, according to a manufacturer press release.

2. Briviact

The FDA approved UCB’s brivaracetam (Briviact) on February 19, 2016.

The drug is indicated as an adjunctive treatment for partial-onset seizures in patients aged 16 years and older with epilepsy.

The most common adverse events reported by patients treated with Briviact include drowsiness, dizziness, fatigue, nausea, and vomiting. Like many epilepsy treatments, the drug also carries risks for aggression, agitation, depression, panic attacks, and suicidal thoughts or attempts.

The Drug Enforcement Administration hopes to classify Briviact within the next several months; once it does, UCB will launch the drug in the United States as a film-coated tablet, oral solution, and injection.

3. Emend

On February 4, 2016, the FDA expanded the indication of Merck’s single-dose fosaprepitant dimeglumine injection (Emend), approving the drug for the prevention of delayed nausea and vomiting in patients undergoing moderately emetogenic chemotherapy (MEC).

Previously approved for the prevention of highly emetogenic chemotherapy (HEC), Emend is now the first intravenous single-dose NK1 receptor antagonist to receive the FDA’s nod for both MEC and HEC. Because the use of Emend as a treatment for established nausea and vomiting has not yet been evaluated, however, providers should not prescribe the drug for that purpose.

The most common adverse effects associated with Emend include fatigue, diarrhea, neutropenia, and asthenia. The drug is contraindicated in patients who are hypersensitive to any of its components, as well as those taking pimozide.

4. Gazyva

The FDA expanded the uses of Roche’s obinutuzumab (Gazyva) on February 26, 2016.

Previously approved for patients with previously untreated chronic lymphocytic leukemia, Gazyva is now indicated for the treatment of follicular lymphoma in patients who did not respond to rituximab (Rituxan), as well as in those whose follicular lymphoma relapsed after treatment.

When using it for these newly-approved purposes, patients should initially take the drug in combination with bendamustine chemotherapy before switching to Gazyva alone.

The most common adverse events associated with the drug’s use include low white blood cell counts, nausea, fatigue, cough, and constipation. Some trial participants also experienced diarrhea, fever, decreased appetite, or vomiting.

5. Harvoni

On February 16, 2016, the FDA approved 2 new indications for Gilead Sciences’ ledipasvir/sofosbuvir (Harvoni), a hepatitis C virus (HCV) medication for patients with advanced liver disease.

These label expansions allows the drug to be used in combination with ribavirin for the treatment of HCV genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis, as well as for the treatment of HCV genotype 1-infected patients with decompensated cirrhosis, including those who have undergone liver transplantation.

With this nod, Harvoni is now approved to treat a broad range of patients, including those with HCV genotypes 1, 4, 5, and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.

The most common adverse events associated with the use of Harvoni include fatigue, headache, and asthenia. The drug is not recommended in patients taking other products containing sofosbuvir.

6. Onzetra Xsail

The FDA recently approved Avanir Pharmaceuticals’ sumatriptan nasal powder (Onzetra Xsail) for the treatment of migraines with or without aura in adults.

The first breath-powered intranasal medication delivery system to receive the FDA’s nod for this purpose, Onzetra is administered through the Xsail delivery device as a 22-mg nasal powder.

Trial participants treated with Onzetra reported pain relief after 30 minutes. The most common adverse events associated with the use of Onzetra include abnormal product taste, nasal discomfort, rhinorrhea, and rhinitis.

7. Sernivo

On February 7, 2016, the FDA approved Promius Pharma’s betamethasone dipropionate 0.05% spray (Sernivo) for the treatment of mild to moderate plaque psoriasis in patients aged 18 years and older.

Trial participants treated with Sernivo reported significant improvements in their condition; however, the spray should not be administered the face, scalp, axilla, or groin, nor should it be used for more than 4 weeks.

The most common adverse events associated with the drug’s use include application site reactions such as burning or stinging, pain, and atrophy.

Promius Pharma, a subsidiary of Dr. Reddy’s, plans to launch Sernivo in the coming quarter.

8. Xeljanz XR

The FDA approved an extended-release formulation of Pfizer's tofacitinib citrate (Xeljanz XR) on February 24, 2016.

Xeljanz XR is indicated for the treatment of rheumatoid arthritis in patients who have not had an adequate response to or who are intolerant of methotrexate. The drug is the first once-daily oral Janus kinanse inhibitor to receive the FDA’s nod for this purpose.

The safety profile of Xeljanz XR as a treatment for children or patients with hepatitis B has yet to be established. In addition, the drug’s use is contraindicated in patients with severe liver problems.

Adverse events associated with the use of Xeljanz XR include upper respiratory tract infections, headache, diarrhea, nasal congestion, sore throat, and runny nose. The drug is also linked with an increased risk of shingles, and it may reduce the body’s ability to fight infections.

9. Zepatier

Last month, the FDA approved Merck’s elbasvir and grazoprevir (Zepatier) for the treatment of chronic HCV genotypes 1 and 4 infections. The drug can be taken for this purpose with or without ribavirin.

The most common adverse effects associated with the use of Zepatier without ribavirin include fatigue, headache, and nausea, while the most common side effects reported by trial participants treated with Zepatier and ribavirin include anemia and headache.

Zepatier is contraindicated in patients with moderate or severe liver impairment.