Biotech Values

[DewDiligence]

FDA issues CRL for MRK’s Suvorexant; issues relate to dosing and it appears that Suvorexant can be approved without new trials:

http://finance.yahoo.com/news/merck-receives-complete-response-letter-120000242.html

In the Complete Response Letter, the FDA advised Merck that:

• the efficacy of suvorexant has been established at doses of 10 mg to 40 mg in elderly and non-elderly adult patients;

• 10 mg should be the starting dose for most patients, and must be available before suvorexant can be approved;

• 15 mg and 20 mg doses would be appropriate in patients in whom the 10 mg dose is well-tolerated but not effective; and

• for patients taking concomitant moderate CYP3A4 inhibitors, a 5 mg dose would be necessary.

In addition, the FDA determined that the safety data do not support the approval of suvorexant 30 mg and 40 mg.

Patinets who want to take 30mg or 40mg will have to double-up, if they can find an MD to prescribe it.