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Monthly News Roundup - June 2017

New Fluoroquinolone Baxdela Approved for Certain Skin Infections

Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and show antibiotic resistance. In response, the FDA has approved Baxdela (delafloxacin), an oral and intravenous (IV) fluoroquinolone antibiotic. Baxdela targets both gram-positive and gram-negative bacteria, including the serious pathogen MRSA (methicillin-resistant Staphylococcus aureus). In Phase 3 non-inferiority studies, Baxdela was shown as effective as vancomycin plus aztreonam at 48-72 hours. Fluoroquinolones as a class have been linked to serious, possibly permanent side effects that may involve the tendons, muscles, joints, nerves, and central nervous system.

FDA Approves Shire’s Once Daily Mydayis for ADHD

This month the U.S. Food and Drug Administration (FDA) cleared Shire’s Mydayis (amphetamine mixed salts), a long-acting stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. In Phase 3 studies a morning dose of Mydayis improved symptoms of ADHD as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP) and the effect lasted up to 16 hours. Common side effects include insomnia, decreased appetite, irritability, and anxiety, among others. Shire expects to make Mydayis commercially available in the third quarter of 2017.

Symjepi: A New Epinephrine Product Approved in a Pre-Filled Syringe

The FDA has approved Symjepi, a new, single-dose, prefilled syringe of epinephrine used for the emergency treatment of allergic reactions (Type I) including anaphylaxis. The product provides two, single dose syringes of epinephrine which is considered the drug of choice in acute anaphylactic reactions involving insect stings, food allergies (such as nuts or shellfish), or medications, among others. The manufacturer reports that Symjepi will have a lower cost, smaller size and more user-friendly design, and is expected to launch later this year. Other brands in the epinephrine autoinjector space include EpiPen, Adrenaclick, and Auvi-Q. Generics are also now available.

Bevyxxa Approved for Longer-Term Prevention of Venous Thromboembolism

In June the FDA approved Portola’s Bevyxxa (betrixaban), an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE). Bevyxxa in indicated for patients hospitalized for an acute medical illness, such as heart failure, stroke, infection or lung disease that results in moderate or severe restricted mobility and other risk factors for VTE. In the Phase 3 APEX study, Bevyxxa reduced the incidence of DVT and PE blood clots compared with enoxaparin plus placebo by 4.4 percent vs. 6.0 percent, respectively, with no significant increase in major bleeding. Portola expects to launch Bevyxxa between August and November 2017.

Genentech’s New Rituxan Hycela May Mean Less Clinic Time

The FDA has given the thumbs up to Genentech’s Rituxan Hycela (rituximab and hyaluronidase human), which includes rituximab plus hyaluronidase human, an enzyme that helps to deliver rituximab under the skin. The product can now be delivered under the skin in minutes instead of hours through an intravenous (IV) infusion. Rituxan Hycela is for adults with the following blood cancers: follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). Clinical studies showed Rituxan Hycela delivered similar blood levels and effectiveness of rituximab. The majority (77 percent) of patients preferred Rituxan Hycela over IV Rituxan due to less time spent in the clinic.

Orally Disintegrating Cotempla XR-ODT Now Approved for ADHD

The FDA has approved Cotempla XR-ODT (methylphenidate), a once-daily, extended-release, orally disintegrating tablet (ODT) for Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. In Phase 3 studies, Cotempla XR-ODT showed a significant improvement in ADHD symptom control compared to placebo across the day in a laboratory classroom setting. Onset of effect was evident at one hour post-dose and lasted through 12 hours. In addition, the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products. Cotempla XR-ODT, from Neos Therapeutics, will be available in the fall of 2017.

FDA Clears Orphan Drug Haegarda for Hereditary Angioedema

Haegarda (C1 esterase inhibitor [human]) was given the FDA go-ahead in June to prevent hereditary angioedema (HAE) attacks in adolescent and adults. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. Haegarda is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy that can be given at home with self-injection. Compared to placebo over 16 weeks, Haegada given twice per week at a dose of either 40 IU/kg or 60 IU/kg led to a significantly reduced number of HAE attacks. Common side effects include injection site reactions, allergic reactions, and nasopharyngitis.

Posted: June 2017


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