Opdivo, Keytruda Back In The News, FDA Snubs AGN, EARS Catches Eyes

(RTTNews) - Today's Daily Dose brings you news about FDA approval of Bristol-Myers' Opdivo and Merck's Keytruda for additional indications; Allergan's disappointment over its antipsychotic medicine VRAYLAR and Auris' progress with its phase III clinical trial of Keyzilen.

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The FDA has refused to accept for review Allergan plc's (AGN) supplemental New Drug Application for Vraylar for treatment of negative symptoms associated with schizophrenia in adult patients, saying that the application is not sufficiently complete. Vraylar, an oral, once daily atypical antipsychotic was approved by the FDA in September 2015 for the treatment of schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder.

In the first half of this year, Vraylar generated net revenue of $119.9 million.

AGN closed Friday's trading at $204.65, up 0.98%.

Auris Medical Holding AG (EARS) has completed the recruitment of patients for its phase III clinical trial of Keyzilen in acute and post-acute inner ear tinnitus, dubbed TACTT3.

The trial enrolled more than 365 patients during both the acute tinnitus stage (Stratum A) and the post-acute tinnitus stage (Stratum B).

The Company expects top-line results from the TACTT3 trial in the first quarter of 2018.

EARS closed Friday's trading at $0.81, up 14.77%.

Bristol-Myers Squibb Co.'s (BMY) immunotherapy wonder drug Opdivo has received FDA approval for yet another indication - this time, for the treatment of patients with hepatocellular carcinoma who have been previously treated with Sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response.

The drug received its first FDA approval in December 2014 for advanced melanoma, and since then has been approved for a number of indications like advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, and MSI-H or dMMR metastatic colorectal cancer.

Opdivo netted global sales of $3.77 billion in full year 2016 and $2.32 billion in the first half of 2017.

BMY closed Friday's trading at $63.36, up 0.05%.

Exelixis Inc.'s (EXEL) partner Daiichi Sankyo Co. Limited has reported positive top-line results from a phase III pivotal trial of Esaxerenone in patients with essential hypertension in Japan, dubbed ESAX-HTN.

In the trial, the primary endpoint is sitting systolic blood pressure (SBP) / diastolic blood pressure (DBP) change from baseline after 12 weeks of treatment, and the secondary endpoint is mean 24-hour SBP/DBP change from baseline after 12 weeks of treatment.

Daiichi Sankyo has also initiated a pivotal trial of Esaxerenone in patients with diabetic nephropathy, dubbed ESAX-DN, in Japan.

Esaxerenone is a product of prior research collaboration between Exelixis and Daiichi Sankyo. While Daiichi Sankyo has exclusive global development, manufacturing, and commercialization rights for Esaxerenone, Exelixis is eligible for substantial clinical development, regulatory, and commercialization milestones, as well as double-digit royalties on sales of the compound.

EXEL closed Friday's trading at $24.47, down 12.64%.

Merck & Co. Inc.'s (MRK) blockbuster drug Keytruda has received FDA approval for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. This indication is approved under the FDA's accelerated approval regulations based on tumor response rate and durability of response.

Keytruda received its first FDA approval in September 2014 for the treatment of metastatic melanoma, and since then, it has been approved for additional indications like metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, classical Hodgkin lymphoma and bladder cancer.

The drug brought home sales of $1.40 billion in 2016 and $1.46 billion in the first half of 2017.

MRK closed Friday's trading at $65.13, down 0.72%.