Looking back at August, we saw seven approvals and three rejections. One drug was recommended for approval and assigned a PDUFA date. Three other drugs were granted Priority Review with future PDUFA Dates.
Prescribe Right will be at the Illinois Council of Health-System Pharmacists in Chicago on September 13 and 14. We look forward to meeting everyone attending. We will be giving demos of the Pharmaceutical Pipeline Tracker on the 13th and 14th and meeting with individuals at the reverse expo on the 14th. The database now provides information for more than 600 drugs and almost 800 citations. Be sure and stop by to see our new feature that allows you to create a chronological list of drugs with PDUFA dates. You can even see the priority review destinations like Orphan Drug, Breakthrough Therapy and Fast Track. Since a priority review usually indicates a budget buster, it is a must have for those responsible for strategically planning a drug budget. We look forward to seeing you in Chicago.
The Pharmaceutical Pipeline Tracker has added new feature. You can now look up a current list of drugs with PDUFA dates and the Priority Designations for those drugs
By clicking on the “Current List of Drugs with PDUFA Dates” button on the main search screen, a scrollable list of potential budget busting investigational drugs is displayed. Included with this new feature is a single click access to the Priority Designations associated with each entity (if any). Only a select number of drugs are deemed eligible for priority review. Typically, those given priority represent significant medical breakthroughs or offer treatment where few or no other options exist. Priority review is often granted to drugs that aim to treat serious medical conditions, though drugs that treat less serious conditions are also eligible for priority review if they meet the criteria. In most cases drugs with a Priority Review are high cost specialty drugs that require special storage, administration technique, monitoring or acquisition barriers that require planning and coordination. Rather than seeking a listing of investigational drugs with PDUFA Dates separately from multiple sources (FDA, pharmacy wholesalers, pharma companies, stock analysts, primary literature) the Pharmaceutical Pipeline Tracker provides that information at the click of a single button from our main search page. Access to any Priority Designations are listed. Basic Flow – At any computer, laptop, or mobile device open a web browser and enter www.prescriberight.com in the search field then hit the enter key on the keyboard. The Home page opens. On the command line hover over “Pharmaceutical Pipeline Tracker” and click on “Access the Tracker” on the drop-down menu. Type in your assigned user name and password. Then hit the Login button. The main search screen appears, at the bottom of which is the “Current List of Drugs with PDUFA Dates” button. Click on that button and the screen displays a scrollable list of drugs with PDUFA dates. Click on any drug name to display a single drug monograph containing the following information: generic name, brand name (if available), pharma company, research code, indication, drug class, route, PDUFA Date, FDA and EU status. Statements on efficacy and safety are present. Published research studies (if available) are accessible via URL links to PubMed. Priority Designations, if any, are available by clicking on the words “Priority Designations” next to the PDUFA Date. To return to the list click on the back arrow. View as many drugs as you wish as many times as you wish. For complete details, request a FREE, no obligation trial subscription to the full Pharmaceutical Pipeline Tracker knowledgebase via the CONTACT button below. View all of our USE CASES at www.prescriberight.com. Six updates we identified from over 200 Informational feeds from research presentations, study publication and news about drugs in development.
You can access up-to-date information on all drugs in the late stages of development with the Prescribe Right Pharmaceutical Pipeline Tracker. Eleven updates we identified from over 200 Informational feeds from research presentations, study publication and news about drugs in development.
There were two approvals on Friday. In a rare, but nice occurrence there was some pricing information available.
You can access up-to-date information on all drugs in the late stages of development with the Prescribe Right Pharmaceutical Pipeline Tracker. Inotersen and patisiran decrease total transthyretin (TTR) production (mutant and non-mutant), which leads to lower levels of all TTR. In hereditary transthyretin amyloidosis (hATTR) clinical trials, treatment with both drugs has decreased neuropathy impairment and improved quality of life measurements.
Patients receiving patisiran are pretreated with dexamethasone, oral acetaminophen, ranitidine or famotidine and diphenhydramine to reduce infusion-related reactions. Patients receiving patisiran should be monitored for infusion reactions and peripheral edema. Patients receiving inotersen must be monitored for thrombocytopenia and changes in renal function. This would require careful titration and monitoring in patients with renal or cardiac disease. These drugs act on TTR and not on correcting the mutation that causes the abnormal TTR to be produced. TTR is a protein found in serum and cerebrospinal fluid, where it transfers thyroxine and retinol. The long-term effect of TTR elimination is unknown. Because the alternate is liver transplantation, patisiran and inotersen will likely be the preferred treatment until a genome edit is created to correct the abnormal protein mutation. Eleven Items of Interest from over 200 Informational feeds from around the Pharmaceutical industry.
In an updated report, ICER has estimated an annual price of $28,800–$42,100 in order for risankizumab to achieve a long-term cost-effectiveness benchmark of $100,000– $150,000 per QALY. ICER suggested that step therapy approaches may not be appropriate for psoriasis. In an analysis of current data ICER found that risankizumab may be more effective than TNF-blockers, but this is based on grey literature, since risankizumab studies have not been published.
Ten Items of Interest from over 200 Informational feeds from around the Pharmaceutical Pipeline ecosphere:
1. FDA OKs Tafenoquine (Krintafel) to Prevent Malaria Relapse GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced FDA approval of tafenoquine (Krintafel) to prevent relapse of Plasmodium vivax malaria in people aged 16 years and older who are receiving appropriate antimalarial therapy for acute P vivax infection. Tafenoquine is the first new agent for P vivax malaria in over 60 years and the only single-dose medicine for this type of relapsing malaria, according to GSK. Tafenoquine was approved under priority review. 2. FDA approves elagolix (Orilissa, AbbVie) treatment for endometriosis Elagolix is the first oral gonadotropin-releasing hormone antagonist specifically developed for treatment of moderate to severe pain associated with endometriosis. It was approved via priority review and is expected to be available in the US next month. The drug, to be sold under the name Orilissa, will carry a list price of about $850 per month, or just over $10,100 per year. The price tag falls within the Institute for Clinical and Economic Review's value-based price benchmark range of $8,800 to $12,800, but could still be a strain on the healthcare system in the short-term due to the number of women with endometriosis. 3. Update on VY-AADC for Parkinson’s Voyager Therapeutics announced likely plans to request approval of VY-AADC as a Parkinson’s gene therapy, based on feedback it received from the FDA and eventual outcomes of a newly opened Phase 2 trial. The company also reported that its Phase 1 trial of VY-AADC showed improvements in patients’ motor function and reduced medication use, along with other benefits, supporting a future biologics license application (BLA). 4. New Analysis of Patisiran Clinical Results Alnylam presented new analyses of results from APOLLO Phase 3 Study at the 2018 Peripheral Nerve Society Annual Meeting. Patisiran-treated patients showed improvements in overall health status compared to placebo. Indirect analysis demonstrated patisiran’s impact on neuropathy and Quality of Life relative to tafamidis. The Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion recommending marketing authorization of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy. If approved by the European Commission (EC), the medicine will be commercialized under the brand name ONPATTRO™. 5. Merck Released Data on Doravirine, a Potential HIV Treatment Merck posted 96-week data on the HIV prospect doravirine it hopes will replace other drugs in combination regimens. The update comes with the PDUFA date just three months away. 6. PRIME Designation of Setmelanotide for Genetic Obesity Disorders Rhythm Pharmaceuticals, Inc, announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for setmelanotide, the company's first-in-class melanocortin-4 receptor (MC4R) agonist, for treatment of obesity and control of hunger associated with rare deficiency disorders of the MC4R pathway. 7. Orphan Drug Status Recommended for OMS721 The Omeros Corporation announced that the European Medicines Agency's (EMA's) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation. 8. Fast Track Designation of APL-2 for Macular Degeneration Apellis Pharmaceuticals Inc. announced that the FDA has granted Fast Track designation to their APL-2, a novel inhibitor of complement factor C3 as a next generation monotherapy for treatment of geographic atrophy (GA), an advanced form of age-related macular degeneration. 9. Athenex’s Skin Ointment for Precancerous Lesions Athenex reported that two Phase 3 trials of its skin ointment for precancerous lesions saw 100% clearance of actinic keratosis growths within 60 days, including in the face and scalp. 10. Positive Opinion on Medicine for Complicated Intraabdominal Infections Tetraphase Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending Xerava (eravacycline) for approval as a treatment for adult patients with complicated intra-abdominal infections (cIAI). The CHMP’s opinion will be reviewed by the European Commission (EC); a final decision is expected within three months. The CHMP opinion is based on data from IGNITE1 and IGNITE4, part of the Phase 3 Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) program. |
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