FDA Advisory Committee Votes 17-1 in Support of Zulresso for PPD

Today the Advisory Committee (ADCOM) voted 17-1 in support of Sage Therapeutics drug Zulresso for Postpartum Depression (PPD). The first and only drug if approved for this unmet medical need, will go into commercialization early 2019 under the name of Zulresso. The press release is here FDA Advisory Committee Votes 17-1. 
The future for the company gets even more exciting with once daily oral drug SAGE-217, which is in phase 3 testing for Major Depressive Disorder or MDD, and has a market potential several times larger than PPD.
SAGE has a talented management team, with plenty of cash to run pivotal clinical trials, and bring new drugs for other indications to market. SAGE-217 has patent to April 2034. Thank you for reading.
 

Vertex Pharmaceuticals Passes Advisory Committee

Vertex's (VRTX) drug combo named Orkambi faced the advisory committee on Tuesday this week. The FDA document is here Orkambi Advisory Committee .  The advisory committee voted 12-1 to approve the combination for patients with Cystic Fibrosis who have two copies (homozygous) of the F508del mutation, 12 years and older.  So that opens their market to a substantially much larger population of 20,000 patients. The results from the two phase 3 studies 890-103 and 890-104 are as follows.

Study 809-103

Lumacaftor 400 mg + Ivacaftor 250 mg q12 at week 24 = 2.6% mean absolute improvement over placebo on FEV1 test.

 

Study 809-104

Lumacaftor 400 mg + Ivacaftor 250 mg q12 at week 24 = 3.0% mean absolute improvement over placebo on FEV1 test.

Orkambi 

Lumacaftor 200 mg + Ivacaftor 125 mg, proposed dose every 12 hours.

Lumacaftor and Ivacaftor was administered twice daily, with the safety profile seen as well tolerated. What's intriguing is the fact that Orkambi the proposed combo up for FDA approval is administered as Lumacaftor 200 mg, and Ivacaftor as 125 mg twice daily. In prior trials, Lumacaftor dosages at the 600 mg level, achieved better efficacy than the 400 mg Lumacaftor dose on FEV1.  The reason for using 400 mg instead of 600 mg, is because the drug-drug interaction of Lumacaftor tends to lessen the effects of Ivacaftor up to 80% as dosages increase. The final date for FDA approval falls on July 5th, of 2015, and in the fourth quarter for EU approval. With an annual therapy per patient price of around $300,000, the potential to achieve revenue up to six billion is attainable. Thank you for reading.