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It's Raining FDA Approvals, NBRV, SESN Hit Trial Goals But Fail To Make A Mark


Today's Daily Dose brings you news about FDA approval of AstraZeneca's hyperkalemia drug; Dova's platelet booster Doptelet getting regulatory nod; the fifth indication for Amgen's Prolia securing thumbs-up; Sesen's encouraging three-month data from the VISTA trial and investors' concern and Nabriva's LEAP 2 study results.

Read on…

Amgen's (AMGN) bone-strengthening drug Prolia (AMGN) has won FDA approval for the fifth indication - i.e., for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture.

In the U.S., Prolia is already indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture; for treatment to increase bone mass in men with osteoporosis at high risk for fracture; as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, and in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer in the U.S.

Last year, Amgen reported Prolia sales of $1.97 billion, a 20% increase over 2016.

AMGN closed Monday's trading at $176.47, up 0.10%.

Twice rejected by the FDA, i.e., in May 2016 and March 2017, AstraZeneca plc's (AZN) Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, has finally got the regulatory nod for the treatment of hyperkalemia in adults.

Hyperkalaemia is a serious condition characterized by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic disease.

Lokelma was approved in the European Union on March 22, 2018.

The drug came under AstraZeneca's fold when it acquired ZS Pharma in 2015 for $2.7 billion.

AZN closed Monday's trading at $36.79, up 1.27%.

Shares of Dova Pharmaceuticals Inc. (DOVA) slumped more than 13% on Monday, despite the FDA approving the Company's platelet booster Doptelet (avatrombopag) for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure. This is the first drug approved by the FDA for this use.

Thrombocytopenia is a condition characterized by abnormally low levels of platelets in the blood, and which is a common complication in patients with chronic liver disease. An estimated 1.1 million chronic liver disease patients in the United States are said to be affected by thrombocytopenia.

The primary intellectual property related to Avatrombopag is licensed to Dova from Astellas on an exclusive, worldwide basis under the terms of a license agreement that was acquired from Eisai.

A drug for a similar indication by the name Lusutrombopag, developed by Shionogi & Co., Ltd., is at the FDA altar, with a decision expected on August 26, 2018.

DOVA closed Monday's trading at $24.16, down 13.20%.

Nabriva Therapeutics plc's (NBRV) second of two global, pivotal phase III clinical trials of Lefamulin for the treatment of community-acquired bacterial pneumonia met all the primary efficacy endpoints. However, despite the positive results, the stock fell more than 16% on concerns about the rate of treatment-emergent adverse events in the trial.

The trial, dubbed LEAP 2, evaluated the safety and efficacy of 5 days of oral Lefamulin against 7 days of oral Moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).

In LEAP 2, Lefamulin met the FDA primary endpoint of non-inferiority compared to moxifloxacin for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population. ECR was 90.8% for the 5-day treatment course of lefamulin and 90.8% for the 7-day treatment course of moxifloxacin.

Lefamulin also met the European Medicines Agency primary endpoint for non-inferiority compared to moxifloxacin.

However, what spooked the investors was the rate of treatment-emergent adverse events- it was 32.6% in the lefamulin arm and 25.0% in the moxifloxacin arm. Three deaths were also reported in each treatment arm, which occurred within 30 days.

NBRV closed Monday's trading at $4.53, down 16.57%.

Sesen Bio Inc.'s (SESN) has reported encouraging three-month data from its ongoing phase III trial of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG), dubbed VISTA. However, with investors worrying about the four treatment-related serious adverse events that were reported in the trial, including acute kidney injury or renal failure and cholestatic hepatitis, the stock slid 23%.

The efficacy data being reported are based on three-month follow-ups from 111 patients with high-grade NMIBC that is either carcinoma in situ (CIS), or from patients with papillary disease without CIS.

According to the Company, VISTA, achieved 42% complete response rate at 3 months in carcinoma in situ patients. Among patients with papillary disease without CIS, treatment with Vicinium demonstrated a 68 percent recurrence-free rate at three months.

The Company expects to present 12-month data of the VISTA trial by mid-2019.

SESN closed Monday's trading at $2.31, down 23.00%.

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