KINECT 4 Study; KindredBio Announces Results; Mylan and Aspen’s Launch; EMA investigates; Amgen’s Repatha

KINECT 4 Phase III Study Demonstrating INGREZZA® Improves Tardive Dyskinesia Symptoms

Neurocrine Biosciences, Inc. announced new long-term data from the KINECT 4 Phase III open-label study demonstrate that once-daily INGREZZA® (valbenazine) capsules, the first FDA approved treatment for adults with tardive dyskinesia (TD), improved TD symptoms through 48 weeks of open-label treatment and was generally well tolerated. TD is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. These data were presented at the ACNP Annual Meeting. In addition to the KINECT 4 Phase III study results, Neurocrine also presented pooled data analyses from three double-blind, placebo-controlled INGREZZA studies (KINECT, KINECT 2 and KINECT 3) across patient sub-groups. Pooled data analyses showed that once-daily INGREZZA improved tardive dyskinesia symptoms and was generally well tolerated in both older and younger adults.

KindredBio Announces Positive Results from Pivotal Study of Zimeta Oral for Fever in Horses

Kindred Biosciences, a biopharmaceutical company focused on saving and improving the lives of pets, announced positive topline results from its pivotal field effectiveness study of Zimeta™ (dipyrone oral gel) for the control of pyrexia (fever) in horses. This study was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 139 horses to assess the effectiveness of Zimeta Oral. The primary endpoint was improvement or resolution of fever 6 hours after treatment. The success rate was approximately 78% in the Zimeta Oral group vs. approximately 18% in the placebo group.  Based on preliminary review of the safety data, the drug appears to be well tolerated. KindredBio has completed the in-life portion of the Target Animal Safety Study and is analyzing the data. The Company anticipates submitting the Effectiveness technical section of the New Animal Drug Application in early 2018, and the Safety and Chemistry, Manufacturing and Controls technical sections in the first half of 2018.

Mylan and Aspen Announce Launch of Generic Busulfex® Injection

Mylan and its partner, Aspen, announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical’s Busulfex® Injection. Aspen received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. As part of its partnership with Aspen, Mylan will commercialize Busulfan Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial in the U.S. Mylan has one of the largest injectable portfolios in the industry and is also one of the largest suppliers of cancer medicines by volume in the U.S. U.S. sales for Busulfan Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial were approximately $97 million for the 12 months ending Sept. 30, 2017.

EMA investigates Allergan blockbuster hopeful Esmya on reports of liver damage

As Allergan chases a U.S. approval for uterine fibroids drug Esmya, across the pond, regulators are investigating the treatment for liver damage. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has launched a review of the product after four cases of serious liver damage turned up among patients, Bernstein’s Ronny Gal wrote in a note to clients. Three of those cases ended in liver transplantation. Allergan, for its part, does not expect the investigation will have an impact on its New Drug Application, while the product’s ability to reach blockbuster heights—as Allergan insists it can—depends on the label’s breadth.

Amgen gets its shot at promoting Repatha to prevent heart attacks and strokes

Amgen has its long-awaited approval to tout Repatha as a cardiovascular prevention tool. On the basis of a massive CV outcomes trial unveiled in March, the FDA blessed the cholesterol drug to fend off heart attacks, strokes and coronary revascularization surgeries in patients with heart disease. In that trial, called Fourier, Repatha reduced heart attack risks by 27%, stroke risks by 21% and coronary revascularizations by 22%. With the FDA approval, Repatha becomes the first in its class of pricey new cholesterol drugs to boast the indication. Amgen has rolled out its economic analyses, including an August report based on the mash-up of Fourier data and real-world numbers. That analysis showed Repatha is cost-effective at $9,669 per year or less—an amount consistent with what’s generally paid after rebates and discounts.