Newly Approved Dermatologic Drugs

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April 11, 2014

Newly Approved Dermatologic Drugs

  1. Jeffrey P. Callen, MD

It is uncanny how the timing of approval of new drugs seems to coincide with the annual meeting of the American Academy of Dermatology. This year was no exception, with at least four recent approvals.

  1. Jeffrey P. Callen, MD

Omalizumab (Xolair), a biologic agent previously approved for use in patients with asthma, has been studied over the past several years for use in patients with refractory chronic idiopathic urticaria (NEJM JW Dermatol Mar 1 2013). Previously, this drug was approved for delivery only in the offices of allergists or immunologists. This new approval1 allows other physicians to utilize the drug; however, the package insert still carries a black box warning that recipients should be monitored for post-injection anaphylaxis. The American Academy of Allery, Asthma, and Immunology guidelines on omalizumab administration liberalize the recommended observation times after the first several injections.

Administration for chronic idiopathic urticarial differs from that for asthma — a fixed dose, not one based on body weight or IgE level, is used.

Bottom line: It is uncertain how many dermatologists will administer this agent given the black box warning.

Apremilast (Otezla) was approved for the treatment of “active” psoriatic arthritis2. This agent inhibits phosphodiesterase 4, which is part of the cyclic adenosine monophosphate pathway. Interestingly, the cyclic AMP pathway was studied in psoriatic patients in the 1970s, and agents were sought that might block the pathway. Though not yet approved, this drug has been studied for use in psoriasis and other inflammatory skin diseases. For patients with psoriatic arthritis, it is approved for use in conjunction with other disease-modifying antirheumatic drugs (DMARDs). If approval is granted for psoriasis, it is likely that it will be for monotherapy.

Bottom line: It will be interesting to track the adoption of this agent and to observe its potential off-label uses in dermatologic patients.

Injectable methotrexate (Otrexup) was recently approved3 for use as preloaded pens for subcutaneous self-injection. Its approved indications are psoriasis, rheumatoid arthritis, and polyarticular juvenile idiopathic arthritis. Four doses are available: 10, 15, 20, and 25 mg. The advantage is possibly increased bioavailability, bypass of the first pass on the liver (unlike with oral methotrexate administration), and ease of use. The disadvantage is the fixed dosing available and perhaps the cost of the product.

Bottom line: For people who fear needles, this delivery system has a lot to offer. Cost to insurers and patients might limit its use.

Luliconazole (Luzu) is a new topical antifungal, approved for superficial fungal infections4. It is an azole cream. Its use is for 2 weeks, with a once-a-day application. Perhaps this agent will offer advantages because application is less frequent, but I don't know that its spectrum of action is better than of other currently available agents. It is now approved for treatment of Trichophyton rubrum and Epidermophyton floccosum only, so it may again become important to culture fungal infections.

Bottom line: We have a new agent to consider for once-daily, effective dosing of tinea pedis, tinea cruris, and tinea corporis.

Editor Disclosures at Time of Publication

  • Disclosures for Jeffrey P. Callen, MD at time of publication Consultant / Advisory board Amgen; Celgene; Xoma Equity Various trust accounts Editorial boards Archives of Dermatology;; UpToDate Leadership positions in professional societies University of Louisville (Division Chief and Program Director)


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