Merck files for Gardasil indication for males

Merck ended an otherwise rocky year on a good note. On announcing the successful completion of a Phase III study of the HPV vaccine Gardasil in young men in November, Merck said the company was on track to submit its sBLA before the end of the year. CNBC reports that the company filed its application with the FDA in December.

Gardasil prevents lesions caused by HPV types 6, 11, 16 and 18. The company hopes to be able to market the drug to males aged 9 to 26, according to CNBC. Merck's Phase III trial demonstrated that the vax prevented 90 percent of external genital lesions caused by the disease in men aged 16 to 26.

The target market--young women--adopted Gardasil early on, making it a blockbuster. Sales have since slowed, but a new indication has the potential to give sales a significant boost. But will it? As BNET points out, HPV does not present the same risks for men as it does for women. Unlike in women, HPV in men is largely symptomless and non-fatal, which will fuel even more debate over the cost-effectiveness of the jab. And with a number of doctors already either opting out or considering dropping various vax programs due to concerns over costs, the likelihood that the the jab will be adopted by the new market doesn't seem as high.

Some have accused Merck of hyping the risks of cervical cancer to boost sales. But others say that the concerns are real. Speaking at a conference in October, the Nobel Prize winning pioneer of HPV research, Dr. Harald sur Hausen, called for the vaccination of males, explaining that certain strains of HPV can cause penile and anal cancer.

- read the WSJ Health Blog post
- check out the report at CNBC
- see the BNet article

Related Articles:
In Phase III, Gardasil prevents HPV in men
HPV researcher calls for vaccination of males
Critics accuse Merck of hyping cervical cancer risk
Study questions cost-effectiveness of Gardasil