FDA Update: July 2017

Jul 11, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Among the U.S. Food and Drug Administration (FDA) actions taken last month were:

Generic Approved for Lialda

The first generic for Shire’s Lialda® (mesalamine) 1.2Gm delayed-release tablets was FDA approved on June 5, 2017. Zydus Cadila was first to file, so it has 180 days of exclusivity for the drug, which is taken orally to treat mild-to-moderate ulcerative colitis. Launch is projected for July or August, but pricing currently is unknown. IMS estimates that global sales for Lialda were $1.2 billion for the 12-month period ending on April 30, 2017.

Symjepi Approved

On Jun. 15, 2017, the FDA approved Adamis Pharmaceuticals’ Symjepi™ (epinephrine) injection for the emergency treatment of allergic reactions (Type I) including anaphylaxis. It is a single-dose, pre-filled syringe for manual injection that contains 0.3mg/0.3mL of epinephrine. The recommended dose for patients who weigh at least 30kg (66 pounds) is one injection, administered intramuscularly (IM) or subcutaneously (SC) into the thigh. Adamis plans to launch Symjepi by mid-summer in a package that contains two syringes. Pricing information is not yet available. However, according to the manufacturer, Symjepi will be discounted to its main competitor, EpiPen® (epinephrine auto-injector). Full prescribing information can be found here.

New Fluoroquinolone Antibiotic Approved

Baxdela™ (delafloxacin) was approved by the FDA on June 19, 2017. It treats adults who have acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Baxdela is the first FDA-approved drug for Melinta Therapeutics, which has not released launch or pricing plans. Available as both oral tablets and intravenous (IV) infusions, Baxdela is dosed at 12 hour intervals for five days to 14 days. One 450mg tablet is equivalent to and interchangeable with one 300mg infusion. All fluoroquinolone antibiotics have the potential to cause tendonitis or tendon ruptures, peripheral neuropathy and central nervous system (CNS). Reactions ranging from dizziness to toxic psychosis. A boxed warning on their labeling alerts patients to the risks and also cautions against their use for patients who have myasthenia gravis. Full prescribing information is available here.

Mydayis Approved for Treating ADHD

FDA approved Shire’s ADHD medication, Mydayis™ (mixed salts of single-entity amphetamine product, CII) capsules on June 20, 2017. It is approved for treating ADHD in patients 13 years of age and older. The recommended starting dose is 12.5mg once daily. If needed, this dose can be titrated by 12.5mg per week to a maximum daily dose of 25mg in children (13 to 17 years) and 50mg per day for adults. Mydayis, which has a duration of action up to 16 hours, is a follow-on to the company’s Adderall XR® (mixed salts of single-entity amphetamine product, CII), which lasts for up to 12 hours. Shire is planning on launching Mydayis 12.5mg, 25mg, 37.5mg and 50mg extended-releases capsules during the third quarter of 2017. Pricing information is not yet available. Full prescribing information can be found here.

Rituxan Hycela Approved

Genentech’s Rituxan Hycela™ (rituximab/hyaluronidase human) for SC injection was FDA approved on June 22, 2017. It is indicated to treat previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma and previously untreated or treated chronic lymphocytic leukemia. Patients can use Rituxan Hycela only after they have received at least one full dose of a rituximab product by IV infusion. While both are administered by a healthcare professional, treatment with Rituxan Hycela can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan. Full prescribing information is available here.

Haegarda Approved for Hereditary Angioedema

The FDA approved CSL Behring’s Haegarda® (C1 esterase inhibitor subcutaneous [human]) on June 22, 2017. It is indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. The recommended dose is 60 international units (IU) of Haegarda per kilogram (kg) of body weight, injected SC twice weekly (every three or four days). CSL Behring plans to launch Haegarda during the third quarter of 2017. Complete prescribing information is available here.

BevyxXa Approved for Clot Prevention

On June 23, 2017, the FDA approved Portola Pharmaceuticals’ BevyxXa™ (betrixaban). It is an oral, once-daily factor Xa inhibitor indicated to prevent venous thromboembolism (VTE) in hospitalized adults with acute illnesses who are at high risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. The recommended dose is an initial dose of 160mg on day 1, followed by 80mg once daily at the same time each day, with food. Treatment should continue for 35 to 42 days. According to Portola, BevyxXa will be available as 40mg and 80mg capsules sometime between August and November 2017. Full prescribing information is available here.

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