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Weekly Drug News Round-Up: September 20, 2017

FDA Approves Mvasi: The First Cancer Biosimilar

A biosimilar is a biological product derived from a living organism deemed highly similar to an already-approved biological product Read More...

The first biosimilar to treat cancer has been approved by the U.S. Food and Drug Administration (FDA) -- Amgen’s Mvasi (bevacizumab-awwb) -- a biosimilar to Genentech’s Avastin (bevacizumab). Mvasi is indicated for multiple types of cancer, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, brain cancer (glioblastoma), metastatic renal cell carcinoma (kidney cancer) and cervical cancers. It is not an interchangeable product with Avastin. The FDA's approval of Mvasi is based on review of safety and effectiveness data that shows Mvasi is highly similar to Avastin. Common expected side effects of Mvasi include nosebleeds, headache, high blood pressure, and inflammation of the nasal cavity, among others.

Solosec Approved as Single Dose Therapy for Bacterial Vaginosis

Solosec is the only single-dose oral therapy for BV, the most common gynecologic infection in the U.S. Read More...

The U.S. Food and Drug Administration (FDA) has approved Symbiomix’s Solosec (secnidazole) 2 gram (g) oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is 5-nitroimidazole, single dose antibiotic with enhanced pharmacokinetic properties. The FDA approval was supported by a comprehensive set of studies including two pivotal trials in BV and an open label safety study which found efficacy for single-dose secnidazole. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported, and no patients discontinued treatment due to adverse events. Solosec will be available commercially in the first quarter of 2018.

FDA Clears Bayer’s Aliqopa for Relapsed Follicular Lymphoma

Roughly 20,000 patients with non-Hodgkin lymphoma will die from the disease in 2017 Read More...

Follicular lymphoma is a slow-growing type of B-cell non-Hodgkin lymphoma, a cancer of the lymph system. This week, the FDA approved Aliqopa (copanlisib), a phosphatidylinositol-3-kinase (PI3K) inhibitor (kinase inhibitor) indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least 2 prior treatments. Aliqopa works by blocking several enzymes that promote cell growth. In a single-arm study with 104 patients 59 percent of patients had a complete or partial response for a median 12.2 months. Common side effects of Aliqopa include high blood sugar levels, diarrhea, decreased energy, and high blood pressure, among others.

Trelegy Ellipta: First Once-Daily, Triple Therapy Inhaler for COPD

In COPD, the inability to breathe normally can make simple activities like walking up stairs an everyday struggle Read More...

Chronic obstructive pulmonary disease (COPD) is a common but serious lung disease that is thought to affect 384 million people worldwide. GSK’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is the first dry powder inhaled corticosteroid, long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) combination available for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It for indicated in those on a fixed-dose combination of fluticasone/vilanterol (Breo Ellipta) who need additional bronchodilation, or who are already using Breo Ellipta and Incruse Ellipta.

Extended-Release Oral Suspension Adzenys ER Approved for ADHD

Adzenys ER will be commercially available in early 2018 Read More...

Last year, the FDA approved Adzenys XR-ODT, the first extended-release orally disintegrating amphetamine tablet for ADHD. Now the FDA has also okayed Adzenys ER (amphetamine), a once-daily, extended-release liquid suspension formulation indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older. Adzenys ER does not require refrigeration or reconstitution at the pharmacy level. It utilizes the same proprietary modified-release drug delivery technology as Adzenys XR-ODT, thereby providing healthcare providers the option to transition patients from liquid to ODT formulations. Both Adzenys ER and Adzenys XR-ODT are manufactured by Neos Therapeutics and are bioequivalent to Adderall XR.