New Combination Treatment for HIV-1 Infection
Mylan announced that the Food and Drug Administration (FDA) has approved Symfi (efavirenz, lamivudine, tenofovir disoproxil fumarate) 600mg/300mg/300mg tablets as a complete regimen for the treatment of HIV-1 infection in adults and children weighing ≥40kg. Symfi contains the same triple combination ingredients found in the recently approved and launched Symfi Lo but with a 600mg dose of efavirenz vs 400mg seen in Symfi Lo. In addition, the FDA recently approved Mylan’s Cimduo (lamivudine, tenofovir disoproxil fumarate) 300mg/300mg tablets intended for use with other antiretroviral agents for the treatment of HIV-1 infection in adults and children weighing ≥35kg. Both Symfi and Cimduo are anticipated to launch in the second quarter of 2018. Symfi Lo is already available as 400mg/300mg/300mg strength tablets in 30-count bottles. Complete prescribing information is at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022142s000lbl.pdf
Bydureon Receives New Indication
On April 2, 2018, the FDA approved Bydureon (exenatide extended-release for injectable suspension) as an add-on to basal insulin in adults with type 2 diabetes who have inadequate glycemic control. Bydureon is currently indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Labeling for Bydureon includes a boxed warning for 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 may be accessed through: www.bydureonhcp.com.
New Combo Treatment Approved for Type of Renal Cancer
On April 16, 2018, the Food & Drug Administration (FDA) approved nivolumab (Opdivo) and ipilimumab (Yervoy) as combination therapy for the treatment of intermediate or poor-risk, previously untreated advanced renal cell carcinoma (RCC). Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already approved to treat various renal carcinomas, urothelial carcinomas, colorectal and hematologic cancers, certain melanomas, and metastatic non-small cell lung cancer (NSCLC). Yervoy, a cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody, is indicated to treat certain unresectable or metastatic melanomas as well as certain cutaneous melanomas. Together, they increase T-cell activity to improve anti-tumor effects against advanced RCC. Treatments using both drugs are given once every three weeks up to four times. Then, Yervoy is discontinued and Opdivo is administered as 240mg once every two weeks or 480mg once every four weeks. Full prescribing information for both drugs can be accessed through: https://www.bms.com/patient-and-caregivers/our-medicines.html.
New Indication for Tagrisso
On April 19, 2018, the FDA approved Tagrisso (osimertinib) as first-line treatment for patients with epidermal growth factor receptor (EGFR)- mutated (exon 19 deletions or exon 21 L858R mutations) metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Tagrisso, a third-generation EGFR tyrosine kinase inhibitor, is already approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TK1 therapy. It is available in 40mg and 80mg strength tablets. For complete prescribing information, please see: https://www.azpicentral.com/tagrisso/tagrisso.pdf#page=1.all
Tafinlar + Mekinist Receive New Indication
On May 4, 2018, the Food and Drug Administration (FDA) approved the combination Tafinlar (dabrafenib) and Mekinist(trametinib) for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body, and is BRAF V600E mutation-positive. Tafinlar and Mekinist are also approved, as monotherapy or in combination, to treat BRAF V600 mutation-positive metastatic melanoma; the combination therapy is also indicated for BRAF V600E mutation-positive, metastatic, non-small cell lung cancer (NSCLC). Recommended dosing for Mekinist is 2mg once a day; for Tafinlar, it is 150mg (two 75mg capsules) twice a day. They can be used separately, but together, they have previous indications for metastatic forms of BRAF V600-mutated melanoma and non-small cell lung cancer (NSCLC). Prescribing information can be found at: https://www.us.tafinlarmekinist.com.
Expanded Indication Approved for Lyrica
On May 7, 2018, the Food and Drug Administration (FDA) has approved an expanded indication for Lyrica (pregabalin) to include adjunctive therapy for the treatment of partial onset seizures in patients as young as 4 years old. Lyrica, a gabapentinoid, is also indicated for the management of: neuropathic pain associated with diabetic peripheral neuropathy; postherpetic neuralgia; fibromyalgia, and neuropathic pain associated with spinal cord injury. Prescribing information for it is at:
Two Drug Combo Approved for Overactive Bladder
On May 1, 2018, the FDA approved two Astellas products, Myrbetriq (mirabegron extended-release tablets) in combination with the muscarinic antagonist VESIcare (solifenacin succinate) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Both drugs alone are used to treat OAB but have different mechanisms by which they do so. Myrbetriq eases tone in the bladder’s detrusor muscle, allowing more urine to be stored. VESIcare helps prevent incidents of incontinence and urinary urgency by keeping the bladder from contracting suddenly. Prescribing information can be found at www.astellas.com
New Bowel Prep Option for Colonoscopy
On May 7, 2018, the FDA approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution; Salix), a low-volume (1 liter) polyethylene glycol based bowel preparation for use prior to colonoscopy. The patient still must drink an equal amount of water or other clear liquid after each dose, however. In contrast to other bowel cleansers that usually need as much as four liters to be taken at a rate of eight ounces every 15 minutes until the entire amount is consumed, Plenvu is separated into two doses that are dispensed in three packets to be mixed with water and taken in order. The first can be used between 4p.m. and 8 p.m. on the day before the colonoscopy or it can be taken the morning of the procedure. The remaining two packets are mixed together in one liter of water to be used between two hours and 12 hours after the first. Plenvu and all other fluids must be finished at least two hours before the colonoscopy is scheduled. Salix plans to launch Plenvu in the U.S. during the third quarter of 2018. Although pricing is not yet available, prescribing information is at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209381s000lbl.pdf
Expanded Use of Gilenya
On May 14, 2018, the FDA expanded the use of Gilenya (fingolimod) to include the treatment of children and adolescents aged 10 to <18 years with relapsing forms of multiple sclerosis (MS). This marks Gilenya as the first disease-modifying therapy approved for this patient group. Gilenya is an oral, disease-modifying drug indicated for treating relapsing forms of multiple sclerosis (MS). The drug is a sphingosine 1-phosphate receptor modulator, which keeps white blood cells from reaching the central nervous system (CNS) where they could damage myelin, the protective covering around nerve fibers. For full prescribing information, please see: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf
New Approval for Prolia
On May 22, 2018, the Food and Drug Administration (FDA) approved the use of Prolia (denosumab) for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture who are either initiating or continuing system glucocorticoids in a daily dosage equivalent to ≥7.5mg of prednisone and expected to remain on glucocorticoids for at least 6 months. n addition to this new indication, Prolia is already approved for: postmenopausal women with osteoporosis at high risk for fracture; men with osteoporosis at high risk for fracture to increase bone mass; men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass; and women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer to increase bone mass. Its recommended dosing is one 60mg subcutaneous (SC) injection given by a healthcare provider twice a year. Additionally, patients should take calcium and vitamin D supplements, daily. Prescribing information is available at: http://pi.amgen.com/united_states/prolia/prolia_pi.pdf.
New Option for Plaque Psoriasis
On May 29, 2018, the Food and Drug Administration (FDA) approved a new indication for Cimzia(certolizumab pegol) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. This marks Cimzia as the first Fc-free, PEGylated, anti-tumor necrosis factor (TNF) treatment option for this indication. Cimzia is already indicated for rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease. Updated prescribing information is available at www.cimzia.com.
Oral Semaglutide Posts Impressive Results vs. Januvia
Novo Nordisk’s oral version of GLP-1 agonist semaglutide (currently in clinical phase 3 clinical trials) reported positive results versus Merck’s DPP-4 Inhibitor Januvia. Data presented at the American Diabetes Association Annual meeting showed head-to-head trial data between the two agents over the course of one year demonstrated 63% of patients in the oral semaglutide arm of the study achieved a target A1c of <7% compared to only 28% of patients in the Januvia arm of the study. This week Novo Nordisk released additional phase 3a data that demonstrated oral semaglutide also did a better job at reducing A1c and weight in the short-run (at 26 weeks) versus Januvia. Semaglutide is currently commercially available as a weekly subcutaneous injection marketed under the brand name Ozempic. An oral formulation of this product would be a first-in-class for a GLP-1 agonist, a market currently dominated by Novo Nordisk’s Victoza and Eli Lilly’s Trulicity.