New Drugs Introduced in 2017: Dermatology

Innovation drives progress, and the FDA’s Center for Drug Evaluation and Research (CDER) fosters process through its governance of the pharmaceutical industry.

New drugs translate to the advancement of health care in the United States, and each year the CDER approves a wide range of new drugs and biological products. In 2015 and 2016, the FDA approved 45 and 29 new therapies, respectively. This year, the FDA is on pace to approve about 38 new medications.¹ Additions to the drug market this year cover a variety of diseases and ailments, providing prescribers with more options and the ability to optimize drug therapy. Part 1 of this series covers new dermatology medications.

Rhofade (oxymetazoline HCl cream, 1%)

The FDA approved Rhofade on January 19, 2017, to treat erythema associated with rosacea.² Erythema is one of the primary signs of rosacea that may resemble a blush or sunburn that does not go away. Persistent erythema may be the source of psychosocial issues for many patients.³

Rhofade is a cream that is to be applied in a thin layer that covers the entire face once a day. Like topical brimonidine, Rhofade is an a₁receptor agonist that causes vasoconstriction to reduce redness associated with rosacea. However, Rhofade is

selective for the alpha_1A subtype.³ This selectivity allows it to exhibit fewer adverse effects than brimonidine.

The most common adverse effects are exacerbation of acne rosacea, application site dermatitis, application site erythema, and application site pain. Adverse effects were relatively rare, with 30 of the 489 subjects in the clinical trials experiencing an adverse effect.³

SILIQ (brodalumab)

The FDA approved brodalumab on February 15, 2017 to treat moderate to severe plaque psoriasis. It is intended for patients who are candidates for systemic therapy/phototherapy for plaque psoriasis and have failed to respond or have stopped responding to other systemic therapies.⁴

Brodalumab is an anti-interleukin 17 receptor-antibody (monoclonal IgG2 antibody) that binds to a protein that causes inflammation, which inhibits the inflammatory response that plays a role in the development of plaque psoriasis. There are additional psoriasis drugs that work similarly, but instead they bind to the protein itself.^4,5,

This medication is dosed as a subcutaneous injection that comes in a 1.5-mL prefilled syringe (210mg/1.5mL). 210 mg is given weekly at weeks 0, 1, and 2, followed by 210 mg once every 2 weeks. Consider discontinuing the medication if an adequate response (defined as reduction in psoriasis area and severity index (PASI) by < 50%) is not achieved after 12 to 16 weeks. Continuing treatment beyond 16 weeks in patients without an adequate response is not likely to result in greater success.^6,7

The most common adverse effects of brodalumab include joint pain, fatigue, increased risk of infection, headache, muscle pain, and injection site reactions. This medication also contains a black box warning for suicidal ideation, and is therefore available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program.⁹

A single 1.5-mL prefilled syringe costs about $2100.00.⁸

Tremfya (guselkumab)

Guselkumab is a new interleukin-23 (IL-23) inhibitor that the FDA approved on July 13, 2017. Guselkumab is the first and only approved treatment that selectively inhibits IL-23 to treat plaque psoriasis, and it is indicated for those with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.^9,10 IL-23 is a cytokine that occurs naturally in the body and is involved in normal inflammatory and immune responses. By inhibiting the release of pro-inflammatory cytokines and chemokines, guselkumab reduces the symptoms of moderate to severe plaque psoriasis.¹¹

Guselkumab is supplied as a 100-mg/ml single-dose syringe to be given as a subcutaneous injection. Patients are to administer a full syringe subcutaneously once at week 0, again at week 4, and every 8 weeks thereafter. Patients should avoid injecting into areas where the skin is tender, bruised, red, hard thick, scaly, or affected by their psoriasis. The prefilled syringe should be removed from the refrigerator, where it should be stored, and allowed to reach room temperature (about 30 minutes) prior to administration.¹¹

The most common adverse effects are increased risk of infection (>10%), as well as headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex virus (>1%). Patients should also be counseled to avoid live vaccines when being treated with guselkumab.¹¹

Guselkumab costs about $10,000 per 1mL syringe.¹⁰

This article was written with Christopher Robinson and Charles Vawters, 2018 PharmD Candidates at the Harrison School of Pharmacy at Auburn University.

References

1.

FDA.

Novel drug approvals for 2017. fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm. Published October 6, 2017. Accessed October 12, 2017.

2.

Allergan announces FDA approval of Rhofade (oxymetazoline hydrochloride) cream,

for the topical treatment of persistent facial erythema associated with rosacea in adults. [news release]. Dublin, Ireland: January 19, 2017. prnewswire.com/news-releases/allergan-announces-fda-approval-of-rhofade-oxymetazoline-hydrochloride-cream-1-for-the-topical-treatment-of-persistent-facial-erythema-associated-with-rosacea-in-adults-300393385.html. Accessed October 12, 2017.

3.

Rhofade [prescribing information]. Irvine, CA; Allergan; 2017.

allergan.com/assets/pdf/rhofade_pi. Accessed October 12, 2017.

4.

FDA approves new psoriasis drug [news release]. February 15, 2017.

fda.gov/newsevents/newsroom/pressannouncements/ucm541981.htm. Accessed October 12, 2017.

5.

MacMillan A. How a new psoriasis drug is different from others. Time Health. time.com/4673630/new-psoriasis-drug-siliq/. Published February 17, 2017. Accessed October 12, 2017.

6.

SILIQ [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2017.

accessdata.fda.gov/drugsatfda_docs/label/2017/761032lbl.pdf. Accessed October 12, 2017.

7.

Mrowietz U, Kragballe K, Reich K, Spuls P, Griffiths CE, Nast A, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011;303(1):1-10. doi:10.1007/s00403-010-1080-1.

8.

Brodalumab. In: Lexi-Comp Online, Lexi-Drugs [internet]. Hudson, OH: Wolters Kluwer Health/Lexi-Comp, Inc. c2017 [cited October 2, 2017].

online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6440125.

9.

CenterWatch.

Tremfya (guselkumab).

centerwatch.com/drug-information/fda-approved-drugs/drug/100212/tremfya-guselkumab. Accessed October 12, 2017.

10.

In: Lexi-Comp Online, Lexi-Drugs [internet]. Hudson, OH: Wolters Kluwer Health/Lexi-Comp, Inc. c2017 [cited October 2, 2017].

online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6518984.

11.

Tremfya [prescribing information]. Horsham, PA: Janssen Biotech, Inc; 2017

accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf. Accessed October 12, 2017.