TrendsRx® April 2010 TrendsRx®Drug Pipeline & News Volume 6, Number 4 Pipeline Highlights: February 26, 2010 – March 25, 2010 and Recent Selected Health Care News Highlights
Selected Generic Product Approvals/Launches1,2*
imiquimod Dosage Form; Strength Cream, topical; 5% (Aldara®) Approval Date† February 25, 2010 Launch Date‡ February 26, 2010 Comments The reference brand is used for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults • Biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured • External genital and perianal warts/condyloma acuminata in patients 12 years old or older This product is AB-rated and will be available from a single generics manufacturer.
tamsulosin Dosage Form; Strength Capsule, oral; 0.4 mg (Flomax®) Approval Date† March 2, 2010 Launch Date‡ March 2, 2010 Comments The reference brand is used for the treatment of the signs and symptoms of benign prostatic hyperplasia. This product is AB-rated and will be available from a single generics manufacturer.
diltiazem Dosage Form; Strengths Tablets, oral, extended-release; 120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg (Cardizem® LA) Approval Date† March 15, 2010 Launch Date‡ March 15, 2010 Comments The reference brand is used for the treatment of hypertension and the management of chronic stable angina. This product is AB-rated and will be available from a single generics manufacturer.
Recent Biologic License Application (BLA) Approvals1,2*
Hizentra® (immune Dosage Form; Strength Injection, subcutaneous; 0.2 g/mL (20%) protein solution globulin Indication For the treatment of primary immunodeficiency subcutaneous Approval Date March 4, 2010 [human]) 20% liquid Anticipated Launch Date‡ April 2010
CSL Behring AG
Recent Supplemental New Drug Application (sNDA) Approvals1,2*
Xifaxan® (rifaximin) Dosage Form Tablet, oral Indication For reduction in the risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age Approval Date March 24, 2010 Comments This is a new indication for an already approved product. Launch of a new strength of the drug (550 mg) is anticipated by the end of May 2010. Salix Pharmaceuticals, Inc. Refer to full Prescribing Information for a complete list of indications.
Continued on next page www.caremark.com Recent Product Launches1,2*
Vpriv™ Dosage Form; Strengths Infusion, intravenous; 200 Units and 400 Units single-use vials (velaglucerase alfa) Indication For long-term enzyme replacement therapy for pediatric and adult patients with type 1 Gaucher disease Shire Human Launch Date‡ March 1, 2010 Genetic Therapies, Inc. Ampyra™ Dosage Form; Strength Tablet, oral, extended-release; 10 mg (dalfampridine) Indication To improve walking in patients with multiple sclerosis Acorda Launch Date‡ March 1, 2010 Therapeutics, Inc. Comments Formerly known as Amaya (fampridine SR) Iprivask® (desirudin) Dosage Form; Strength Injection, subcutaneous; 15.75 mg Indication For the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery Canyon Launch Date‡ March 1, 2010 Pharmaceuticals Comments Iprivask was approved April 4, 2003 Mirapex® ER Dosage Form; Strengths Tablet, oral, extended-release; 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg (pramipexole) Indication For treatment of the signs and symptoms of early Parkinson’s disease Launch Date‡ March 2010 Boehringer Ingelheim International GmbH Cayston® (aztreonam) Dosage Form; Strength Solution, inhalation; 75 mg Indication To improve respiratory symptoms in cystic fibrosis patients withPseudomonas aeruginosa Gilead Sciences, Inc. Launch Date‡ March 1, 2010 Xiaflex™ (collagenase Dosage Form; Strength Injection; 0.9 mg clostridium Indication For the treatment of adult patients with Dupuytren’s contracture with a palpable cord histolyticum) Launch Date‡ March 5, 2010 Auxilium Pharmaceuticals, Inc. Istodax® Dosage Form; Strength Injection, intravenous (infusion); 10mg/vial (romidepsin) Indication For treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy ‡ Gloucester Launch Date March 1, 2010 Pharmaceuticals, Inc. Zyprexa® Relprevv™ Dosage Form; Strengths Injectable suspension, deep intramuscular gluteal, extended-release; 210 mg, 300 mg, and 405 mg base/vial (olanzapine) Indication For the treatment of schizophrenia ‡ Eli Lilly and Co. Launch Date March 5, 2010 Prevnar 13™ Dosage Form; Strength Injection, intramuscular; 0.5 mL single-dose, pre-filled syringe (pneumococcal Indications For the active immunization of children 6 weeks through 5 years of age (prior to the 6th birthday) for the prevention of: 13 valent conjugate • Invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F vaccine [diphtheria • Otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F ‡ CRM197 protein]) Launch Date March 15, 2010 Wyeth Pharmaceuticals Inc.
Wilate® Dosage Form; Strengths Injection, intravenous; (von Willebrand • 450 IU VWF:RCo and 450 IU FVIII activities in 5 mL factor (VWF)/ • 900 IU VWF:RCo and 900 IU FVIII activities in 10 mL coagulation factor Indications For the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) VIII complex [human]) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated Octapharma Launch Date‡ March 15, 2010 Pharmazeutika Produktionsges.m.b.H.
Continued on next page www.caremark.com Recent New Drug Application (NDA) Approvals1,2*
Exalgo™ Dosage Form; Strengths Tablet, oral, extended-release; 8 mg, 12 mg and 16 mg (hydromorphone) Indication For the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time Approval Date March 1, 2010 ALZA Corporation Anticipated Launch Date‡ 2010 Trelstar® Dosage Form; Strengths Injection, intramuscular; 3.75mg, 11.25mg and 22.5mg (triptorelin pamoate) Indication For the palliative treatment of advanced prostate cancer Approval Date March 10, 2010 Watson Pharma, Inc. Anticipated Launch Date‡ May 2010 Differin® (adapalene) Dosage Form; Strength Topical, lotion; 0.1% Indication For the topical treatment of acne vulgaris in patients 12 years and older Galderma Production Approval Date March 17, 2010 Canada Inc. Anticipated Launch Date‡ April 2010 Silenor® (doxepin) Dosage Form; Strengths Tablet, oral; 3mg and 6 mg Indication For the treatment of insomnia characterized by difficulties with sleep maintenance Somaxon Approval Date March 17, 2010 Pharmaceuticals, Inc. Anticipated Launch Date‡ Second half of 2010 Carbaglu® Dosage Form; Strength Tablet, oral; 200 mg (carglumic acid) Indications • Adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N- acetylglutamate synthase (NAGS) • Maintenance therapy for the treatment of chronic hyperammonemia due to the deficiency of the hepatic enzyme NAGS Approval Date March 18, 2010 Orphan Europe SARL Anticipated Launch Date‡ TBD
Recent Supplemental Biologic License Application (sBLA) Approvals1,2*
Botox® Dosage Form Injection, intramuscular (onabotulinumtoxinA) Indication For the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors Approval Date March 9, 2010 Comments This is a new indication for an already approved product. This product will be available through the CVS Caremark Specialty Pharmacy Services Network. Allergan, Inc.
* Adapted from RxPipeline Services Week In Review. For more information, contact: [email protected]
Continued on next page www.caremark.com highest dose of simvastatin experienced higher rates of muscle damage than those prescribed lower doses. The agency also found that despite dose limitations and drug-drug interactions, patients continue to be prescribed higher doses of simvastatin concurrently with medications that are known to increase the risk of rhabdomyolysis.
Myopathy is a known side effect of statin medications and is defined as muscle damage that can cause muscle pain, cramping and weakness. Rhabdomyolysis, the most serious form of myopathy, occurs when the protein myoglobin is released as muscle fibers break down, and can result in kidney damage. Myopathy and rhabdomyolosis are rare side effects; the incidence increases with higher doses of the drugs.
The FDA’s alert is part of its ongoing effort to evaluate the risk of myopathy associated with simvastatin. Recent warnings associated with simvastatin include one regarding a heightened risk of rhabdomyolysis when it is used with the heart medication amiodarone, and a labeling revision that cautions against its use with niacin-containing products in patients of Chinese descent, due to the higher incidence of myopathy.
The FDA asks health care providers to take into consideration a patient’s medical history, concurrent medications and other cholesterol-lowering treatments before starting simvastatin therapy. The agency also recommends that patients continue to take simvastatin but contact their physician if they experience muscle pain, weakness, urine that is dark or red-colored, or any unexplained fatigue.
The FDA will publish an updated statement once this drug review is complete. Clinical Guidelines World Health Organization (WHO) Updated Guidelines for the Treatment of Malaria5,6 In March 2010, WHO announced that the organization would release an updated guideline for the treatment of malaria and the first international guidance on acquiring safe and efficacious antimalarial medicines. Some of the changes from the first edition of the guidelines, published in 2006, include the addition of a new artemisinin-based combination therapy (ACT) and an emphasis on pathogen diagnosis before treatment. The following list includes a few of the new recommendations. • Prompt parasitological confirmation by microscopy, or alternatively by rapid diagnostic tests, is recommended before starting therapy in all patients suspected of malaria. Treatment of malaria based solely on clinical suspicion should only be considered when a parasitological diagnosis is not accessible. • ACTs are preferred over sulfadoxinepyrimethamine plus amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria. • Dihydroartemisinin plus piperaquine is a new ACT option for the first-line treatment of uncomplicated P. falciparum malaria worldwide. • Intravenous artesunate should be used in preference to quinine for the treatment of severe P. falciparum malaria in adults.
The updated guideline also emphasizes proper selection of and adherence to recommended medication regimens to prevent the development of drug resistance.
References: 1. CVS Caremark. RxPipeline. Available at: www.caremark.com/wps/portal/client. Accessed March 5, 2010; March 12, 2010; March 19, 2010; and March 26, 2010. 2. Drugs@FDA. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed March 2010. 3. Facts & Comparisons. Facts & Comparisons Web site. http://www.factsandcomparisons.com/. Accessed March 2010. 4. FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm204882.htm. Accessed March 26, 2010. 5. World Health Organization. WHO releases new malaria guidelines for treatment and procurement of medicines. Geneva, Switzerland: World Health Organization; 2010. http://www.who.int/mediacentre/news/releases/2010/malaria_20100308/en/ index.html. Accessed March 24, 2009. 6. World Health Organization Guidelines for the Treatment of Malaria. Second Edition. 2010, World Health Organization. http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf. Accessed March 26, 2010.
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