FDA Update: November 2017

Nov 9, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Last month, the Express Scripts Emerging Therapeutics team focused on several U.S. Food and Drug Administration (FDA) approvals for new drugs, generics, indications, strengths and dosage forms.

Generic to Copaxone 40mg/mL Approved

On Oct. 3, 2017, Mylan received approval from the FDA for glatiramer injection 40mg/mL, the first A-rated generic to Teva’s Copaxone® 40mg/mL. At the same time, Mylan’s 20 mg/mL glatiramer also was approved. Both are used to treat relapsing multiple sclerosis (RMS) with the 40mg/mL strength self-injected subcutaneously three times a week and the 20mg/mL strength used daily. As one of the first applications to file for a generic to Copaxone 40mg/mL, the company may be eligible for “shared” generic exclusivity for the higher strength.

Higher Strength Approved for Ingrezza

An 80mg strength capsule for Ingrezza® (valbenazine) was FDA approved on Oct. 5, 2017. Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated to treat tardive dyskinesia (TD) for adults. TD typically involves uncontrollable movements of the face, including the eyes, jaw, lips and tongue; but it also can affect other parts of the body. It is a side effect from long-term use of some drugs – primarily antipsychotics. Recommended dosing for Ingrezza is 40mg per day for the first week, then an increase to 80mg once a day. Full prescribing information is available here

Zilretta Approved for Osteoarthritis of the Knee

The FDA approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension) on Oct. 6, 2017. It is a one-time-only corticosteroid treatment administered as a single intra-articular injection (directly into the affected joints) to ease pain associated with knee osteoarthritis. Relief extends over approximately three months. Currently, it is not indicated for use by any other route of injection or in any other joints. It is to be administered by specialists, such as rheumatologists and orthopedists, in an office or clinic setting. Zilretta is expected to list at a cost of about $570 per injection. Flexion Therapeutics started introducing it in October, with a full launch later in the year. Prescribing information is available here.

FDA Approval for Lyrica CR

On Oct. 11, 2017, the FDA approved Lyrica® CR (pregabalin) extended-release tablets. It is indicated for once-daily use to treat diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN). Like Lyrica, which is taken two or three times a day, the extended-release version is a C-V controlled substance. Its recommended dosing is 165mg after the evening meal. If needed, doses can be increased to as much as 330mg/day for DPN or up to 660mg/day for PHN. It will be available in strengths of 82.5mg, 165mg and 330mg. Pfizer expects to launch it in January 2018. Lyrica CR is not approved for fibromyalgia or seizures. Complete prescribing information can be found here.

CAR-T Therapy Approved for B-Cell Lymphomas

Yescarta™ (axicabtagene ciloleucel), a chimeric antigen receptor (CAR)-T treatment for specific types of lymphoma, was approved by the FDA on Oct. 18, 2017. The gene therapy is indicated to treat adult patients with relapsed or refractory forms of non-Hodgkin lymphoma (NHL), which include diffuse large-B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) or transformed follicular lymphoma (TFL) that already has been treated at least twice with other drugs. Yescarta will be administered in certified facilities by healthcare professionals trained in its use. Complete prescribing information is available here.

FDA Expands Approved Use of Stelara

The FDA approved the expanded the use of Stelara® (ustekinumab – Janssen Biotech), a human interleukin-12 and -23 antagonist, on Oct. 13, 2017. Its psoriasis indication has now been expanded to include treatment of adolescent patients as young as 12 years of age. The recommended dose is determined by the weight of the patient. It is given as subcutaneous injections once every 12 weeks after the first two injections, which are given four weeks apart. Plaque psoriasis is an autoimmune inflammatory condition that causes itchy, white patches on the skin. Stelara is also approved for treating adults who have psoriatic arthritis (PsA) and Crohn’s disease. Full prescribing information is available here.

GlaxoSmithKline’s Shingles Vaccine Approved

On Oct. 20, 2017, Shingrix (zoster vaccine recombinant, adjuvanted) received approval from the FDA. Given as two intramuscular (IM) injections between two months and six months apart, it is indicated to prevent shingles (herpes zoster) for adults who are 50 years old or older. In clinical studies, Shingrix was effective for approximately 90% of patients in preventing both acute shingles and the postherpetic neuralgia (PHN) that follows it for up to one-fifth of patients with shingles. On Oct. 25, 2017, the Advisory Council on Immunization Practices of the Centers for Disease Control and Prevention (CDC) voted to recommend Shingrix as the preferred shingles vaccine in the U.S. The council also suggested re-vaccination for individuals who already had been vaccinated with Merck’s less effective Zostavax® (zoster vaccine, live), which has been the only shingles vaccine available in the U.S. since its approval in May 2006. Additionally, the council lowered the age at which the vaccination should be given from 60 years old to 50 years old. Although chickenpox and shingles are caused by same virus that may reactivate as individuals age and their immune systems weaken, Shingrix is not intended for use by children. It does not prevent chickenpox. GlaxoSmithKline plans to launch it soon, but a definite date has not been announced. List price is expected to be about $140 per injection. Full prescribing information is available here.

Simponi Aria Gets Additional Indications

Simponi Aria® (golimumab - Janssen) was FDA approved on Oct. 20, 2017, for treating active cases of PsA and ankylosing spondylitis (AS) among adults. It was first approved by the FDA to treat rheumatoid arthritis (RA) in 2013. A tumor necrosis factor (TNF) blocker, Simponi Aria is given by intravenous (IV) infusion once every eight weeks after two doses are administered in the first four weeks of treatment. Recommended dosing is 2mg/Kg of the patient’s body weight. All TNF blockers have the potential, listed in boxed warnings on their labeling, to cause severe infections that may include tuberculosis (TB). They carry a further warning that use by children or teens has been associated with cases of lymphoma or other cancers. Prescribing information for Simponi Aria can be found here.

New Dosage Form for Exenatide

The FDA has approved a new dosage form of AstraZeneca’s glucagon-like peptide-1 (GLP-1) receptor agonist. Bydureon® BCise™ (exenatide extended release), approved on Oct. 20, 2017, is self-injected once a week. It treats adults who have type 2 diabetes and whose blood sugar needs additional lowering despite diet changes, exercise and one or more oral antidiabetes medications. It will be dispensed in disposable, pre-filled devices that contain the recommended dose of 2mg. Bydureon BCise should not be used along with insulin or as the first treatment for diabetes. Labeling for it includes a boxed warning for patients or close relatives of patients who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), because GLP-1 agonists may cause some types of thyroid tumors. Pancreatitis also is possible during its use. Prescribing information is available here.

Myasthenia Gravis Indication for Soliris

On Oct. 23, 2017, Alexion Pharmaceuticals received FDA approval of its complement inhibitor, Soliris® (eculizumab), for treating some patients with generalized myasthenia gravis (gMG). Believed to affect as many as 60,000 Americans, MG is an autoimmune condition that progressively weakens muscles. For patients, abnormal proteins, including specific antibodies, interfere with acetylcholine, a neurotransmitter that prompts muscles to contract. Symptoms usually begin for women before 40 years of age, but after 60 years of age for men. Vision problems, such as double vision, and difficulties with speaking or swallowing are common initial symptoms as the small muscles in the head weaken. Symptoms improve when the affected muscles are rested. Eventually, however, larger muscle groups are involved and most patients experience increasing fatigue, develop breathing problems and lose freedom of movement. Soliris is indicated for the 5% to 10% of patients with generalized MG who test positive for anti-acetylcholine receptor (AchR) antibodies. Recommended dosing is by IV infusion at 900mg each week for four weeks; 1,200mg in the fifth week and then 1,200mg once every two weeks. One vial (300mg) of Soliris retails for about $7,200. It has previous approvals for two other rare conditions, paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) that together are estimated to have only a few thousand U.S. patients. Soliris must be administered by specially trained and certified providers under a risk evaluation and mitigation strategy (REMS). It has a boxed warning about possibly severe meningococcal infections that have been associated with its use. Updated prescribing information for Soliris is available here.

Intravenous Varubi Approved

The FDA approved an IV form of Varubi® (rolapitant - Tesaro) on Oct. 25, 2017. It is indicated to be used along with dexamethasone and a 5-HT3 receptor antagonist, such as ondansetron, to prevent delayed nausea and vomiting caused by emetogenic (nausea-producing) cancer chemotherapy (chemo). Available for about two years in oral tablet form, it works by blocking receptors for human substance P/neurokinin 1 (NK-1), which contributes to chemo-induced nausea and vomiting (CINV). Dosing is 166.5mg (one vial) given over 30 minutes no more than two hours before chemo begins. Doses of Varubi IV should be separated by at least two weeks. With launch planned for November, it will be dispensed in single-dose vials of injectable emulsion that does not need to be reconstituted or diluted before administration. Prescribing information can be found here.

Generic for Coreg CR

Sun Pharmaceutical Industries was granted FDA approval for its generic of Coreg CR® (carvedilol - GlaxoSmithKline) extended-release capsules on Oct. 25, 2017. An alpha/beta blocker, carvedilol treats high blood pressure, heart failure and other heart conditions. The extended-release version is taken once daily. Generics will be available in the same four strengths (10mg, 20mg, 40mg and 80mg) as the brand. Sun has not released its launch or pricing plans. QuintilesIMS estimates that U.S. sales of Coreg CR amounted to $208 million for the 12-months ended on Aug. 31, 2017.

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