FDA: ¿Nuevo medicamento innovador?

Estimados amigos,

No creo que fuera una «inocentada» del día 28 de diciembre, pero el 29 de diciembre se informó que el Comité de la FDA para productos Dermatológicos y Oftalmológicos decidió por 9 a 0 votos proponer la autorización de la FDA a la solicitud de registro de BIMATOPROST (Limugan, en colirio para glaucoma) con una nueva indicación terapéutica: «ENDURECER, ALARGAR Y OSCURECER LAS PESTAÑAS».

Para febrero de 2009 el laboratorio Allergan lanzará como Latisse con un aplicador especial para las pestañas, esta nueva «innovación terapéutica»:
El texto siguiente, ofrecido por la asociacion DIA del Wall Street Journal, no tiene desperdicio: ‘puede oscurecer zonas de la piel cercanas a los párpados, así como inducir el crecimiento de vello/pelo en zonas colindantes a la aplicación.

Un ejemplo más de cómo aprovechar para terapéutica un efecto adverso colateral (en pacientes de glaucoma, el colirio Limugan puede producir estos efectos no deseados, antes, pues ahora ya lo serán. ¡La estética, al diseño de nuevas moléculas farmacológicas! ¡¡¡En épocas de crisis, todo se aprovecha!!!!

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Allergan wins FDA approval to market eyelash enhancer.

The Wall Street Journal: (12/27, B5, Rundle) reported that «Allergan, Inc. said it received Food and Drug Administration (FDA) approval to market Latisse, a beauty treatment that increases the length, thickness, and darkness of eyelashes by using» bimatoprost, «a drug the company developed to treat glaucoma» that sells «under the brand name Lumigan. The drug’s use as a beauty aid was discovered by patients and eye doctors, who have reported for years that a side effect of the Lumigan drops is enhanced eyelashes.» According to Allergan, «Latisse’s retail price will be $120 for a 30-day supply bottle for both eyes. The treatment is applied daily to the base of the upper lashes with a disposable applicator.»

Allergan said that «‘full results’ occur in 16 weeks,» Bloomberg News (12/27, Larkin) added. The company noted that «lashes could grow differently in one eye from the other in a single patient,» including «differences in ‘length, thickness, fullness,’ color, and direction of the hair growth.» Still, on Dec. 5, the «FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 9-0…that the benefits of Latisse outweighed its risks.» In addition, the panel «recommended that Allergan study use of the drug in certain patient groups once it is approved, including young people and cancer patients who have lost their eyelashes because of chemotherapy.»

According to WebMD (12/26, Hitti), Latisse «will be available by prescription.» If the product «is stopped, eyelashes will gradually return to their previous appearance as new eyelashes grow in.» Additionally, «Latisse may cause darkening of the eyelid skin, which may be reversible, and it ‘may also cause increased brown pigmentation of the colored part of the eye, which is likely to be permanent,'» Allergan said. The product «may also promote hair growth in other skin areas that it frequently touches, so Allergan recommends blotting it off any skin other than the upper eyelid’s lash line to prevent that side effect.» The company said that «Latisse was well-tolerated in its clinical trials, with the most common side effects being eye redness, itchy eyes, and skin hyperpigmentation.
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Para todos, un Feliz Anno Nueve (2009)!

Mariano Madurga