FDA Responds to New Drug Application for Baricitinib

Oxycodone Tablets Submitted to FDA

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Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).¹ The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an immediate-release formulation of oxycodone for treating acute and chronic moderate to severe pain for which the use of an opioid is appropriate.

Initially approved in December 2015 in both 5 and 7.5 mg doses, the treatment is designed to discourage intranasal abuse. It contains an inactive ingredient that may cause nasal burning if the formulation is manipulated and snorted. However, this formulation has not been proved to reduce abuse compared with immediate-release oxycodone.

The FDA is expected to review these formulations for potential approval by mid-June 2017.

NICE Recommends Secukinumab Use for Psoriatic Arthritis

Secukinumab (Cosentyx) is an interleukin 17A inhibitor clinically shown to significantly improve skin and joint symptoms in patients with psoriatic arthritis, while improving patients’ physical function and quality of life. In the U.K., the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Determination, recommending to the National Health Service (NHS) the use of secukinumab in adults with active and progressive psoriatic arthritis.² The treatment is also recommended for use by patients with peripheral arthritis who have three or more tender and swollen joints without having a prior response to at least two standard disease-modifying anti-rheumatic drugs (DMARDs), either as mono- or combination therapy. Secukinumab can also be used in patients who are unresponsive to a TNF-alpha inhibitor within the first 12 weeks, or when TNF-alpha inhibitors are contraindicated. The NICE recommendation acknowledges the clinical importance of secukinumab as a new standard for treating psoriatic arthritis patients.

In July 2015, NICE approved secukinumab for restricted use within the NHS, in Wales and England, to treat adults with moderate to severe plaque psoriasis. In August 2016, the NHS approved secukinumab to treat adults with ankylosing spondylitis when non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors were not suitable or were ineffective.

In the U.K., the National Institute for Health & Care Excellence has published a positive Final Appraisal Determination, recommending to the National Health Service the use of secukinumab in adults with active & progressive psoriatic arthritis.

FDA Responds to Baricitinib New Drug Application

The FDA issued a complete response letter to the New Drug Application for baricitinib, a once daily, oral JAK inhibitor. The manufacturers are seeking approval for baricitinib to treat moderate to severe rheumatoid arthritis (RA). The FDA refused to approve the application in its current form, saying that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms.³

The manufacturers, Eli Lilly and Incyte Corp., will continue to work with the FDA toward the approval of baricitinib. The manufacturers conducted four successful Phase 3 clinical trials with baricitinib as a treatment for patients with moderate to severe active RA, including the RA-BEGIN and RA-BEAM studies. The clinical trials included wide ranges of patients, such as those who were methotrexate naive and inadequate responders to methotrexate, as well as inadequate responders to conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biologic DMARDs, including TNF inhibitors.

Baricitinib was approved for use in the European Union in February 2017.

No REMS for Erythropoiesis-Stimulating Agents

The erythropoiesis-stimulating agents (ESAs), epoetin alfa and darbepoetin alfa, are FDA approved for treating anemia due to chronic kidney disease, chemotherapy and HIV treatments, as well as to reduce the number of blood transfusions associated with certain major surgeries. Recently, the FDA determined that the Risk Evaluation and Mitigation Strategy (REMS) for these treatments is no longer needed for their use in patients with myelosuppressive chemotherapy-related anemia. This change will ensure that the benefits of using these ESAs outweigh their risks of shortening overall survival and/or increasing risk of tumor progression or recurrence in patients with cancer.⁴

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Egalet Corp. News release: Egalet announces U.S. Food and Drug Administration acceptance of file for prior approval supplement for Oxaydo (oxycodone HCl, USP) tablets C-II 10 mg and 15 mg dosage strengths. 2017 April 18.
2. McKee S. NICE nod for Novartis’ Cosentyx in PsA. PharmTimes Online. 2017 Apr 19.
3. Eli Lilly and Company. News release: U.S. FDA issues complete response letter for baricitinib. 2017 Apr 14.
4. U.S. Food and Drug Administration. Post-market drug safety information for patients and providers: Information on erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp). 2017 Apr 13.