5 New FDA Approvals to Know from May 2017

Learn about the new products and expanded indications approved by the FDA in May 2017.

1. Bavencio

The FDA expanded the indication of Pfizer’s avelumab injection (Bavencio) on May 9, 2017.¹

With this nod, Bavencia can now be used for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing therapy

The drug was initially approved in March 2017 for the treatment of Merkel cell carcinoma in patients aged 12 years and older. The first medication to be indicated for this purpose, Bavencio is designed prevent tumor cells from using programmed death ligand (PD-L1) antibodies as protection against white blood cells.

Adverse events associated with the drug’s use include fatigue, infusion-related reaction, muscoskeletal pain, nausea, hypophagia, and urinary tract infection.

2. Bunavail

The FDA expanded the indication of BioDelivery Sciences International's buprenorphine and naloxone buccal film (Bunavail) on May 2, 2017.²

Previously approved for the maintenance treatment phase of opioid dependence treatment, Bunavail can now be used for the initiation of buprenophine treatment in opioid-dependent patients. The drug should be used as part of a complete treatment plan that includes counseling and psychosocial support, according to the manufacturer.

The most common adverse events reported by patients treated with Bunavail include headache, drug withdrawal syndrome, lethargy, sweating, constipation, decrease in sleep, fatigue, and sleepiness.

3. Kalydeco

The FDA expanded the indication of approval of Vertex Pharmaceuticals’ ivacaftor (Kalydeco) on May 17, 2017.³

Kalydeco was previously approved for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have 1 of 10 rare mutations of the CFTR gene. With this latest nod, the FDA increased the number of approved gene mutations to 33, an action that can potentially affect up to 3% of the CF population.

The drug, a CFTR potentiator, is available as either tablets or oral granules, and is to be taken 2 times a day with food containing fat.

Adverse events associated with the use of Kalydeco include headache, upper respiratory tract infection, stomach pain, diarrhea, rash, nausea, and dizziness.

4. Kevzara

The FDA approved Sanofi and Regeneron Pharmaceuticals’ sarilumab (Kevzara) May 22, 2017.⁴

Kevzara is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to 1 or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate. It can be used as monotherapy or in combination with methotrexate or other DMARDs.

Patients should administer 200 mg of the drug via subcutaneous injection once every 2 weeks, though this dosage can be reduced to 150 mg once every 2 weeks if needed.

The most common adverse events reported by trial participants treated with Kevzara include neutropenia, increased alanine aminotransferase, injection site erythema, upper respiratory infections, and urinary tract infections. The drug’s use is also linked to an increased risk of serious infections that may lead to hospitalization or death.

5. Radicava

The FDA approved Mitsubishi Tanabe Pharma’s edaravone (Radicava) on May 5, 2017.⁵

Radicava is indicated for the treatment of amyotrophic lateral sclerosis (ALS). It is the first new ALS therapy to receive the agency’s nod in several years.

The drug should be administered via intravenous infusion with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug free period. Subsequent treatment cycles include dosing on 10 of those 14 days, followed by a 14-day drug free period.

Adverse events associated with the use of Radicava include bruising, gait disturbance, hives, swelling, shortness of breath, and allergic reactions to sodium bisulfite.

References

• FDA grants Bavencio (avelumab) approval for a common type of advanced bladder [news release]. Pfizer’s website. http://www.pfizer.com/news/press-release/press-release-detail/fda_grants_bavencio_avelumab_approval_for_a_common_type_of_advanced_bladder_cancer. Accessed May 10, 2017.
• BioDelivery Sciences announces the approval of Bunavail for induction of buprenorphine treatment for opioid dependence [news release]. BDSI's website. http://bdsi.investorroom.com/2017-05-02-BioDelivery-Sciences-Announces-the-Approval-of-BUNAVAIL-R-for-Induction-of-Buprenorphine-Treatment-for-Opioid-Dependence. Accessed May 2, 2017.
• FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm559212.htm. Accessed May 18, 2017.
• Sanofi and Regeneron announce FDA approval of Kevzara (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients [news release]. Sanofi’s website. http://www.news.sanofi.us/2017-05-22-Sanofi-and-Regeneron-Announce-FDA-Approval-of-Kevzara-R-sarilumab-for-the-Treatment-of-Moderately-to-Severely-Active-Rheumatoid-Arthritis-in-Adult-Patients. Accessed May 23, 2017.
• FDA approves drug to treat ALS [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm. Accessed May 6, 2017.