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    FDA’s 2016 Approvals of New Drugs, Formulations, Strengths & More

    FDA’s 2016 Approvals of New Drugs, Formulations, Strengths & More

    After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines. This week, PharmaCompass, shares its analysis of the new drug approvals by the FDA in 2016. Reasons behind the low approvals in 2016   Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications.   The 9 orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013. The reasons for the low 2016 approval count, have been attributed to the agency approving five drugs in 2015 that actually had approval action dates in 2016 and an increase in the number of drugs that the agency rejected. A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Gilead’s Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection, is expected to become the most profitable approval of 2016 with expected sales of $ 8.4 billion by 2022.  2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States.  Approvals of three biosimilars which target $ 33 billion in brand drug sales   In a giant leap for the generic pharmaceutical industry, three biosimilar applications were approved in 2016 that target brand drugs which generated more than $ 33 billion in sales last year.   All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions.  Pfizer and Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016. After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $ 9.1 billion). On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!   Kim Kardashian’s pregnancy drug is now available in a new strength   Diclegis, a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’ Duchesnay, the company which produces Diclegis, got approval for Bonjesta which combines twice the amount of doxylamine and pyridoxine when compared with Diclegis which contains 10mg of each ingredient. Indian generic companies get approvals for differentiated products   As the generic industry in the U.S. continues to face severe pricing pressure, Indian generic companies are attempting to overcome these challenges by trying to move up the value chain by supplying differentiated generic products. Consistent with this strategy, the applications of Sun Pharmaceuticals for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!   Pfizer launches an opioid treatment with abuse-deterrent properties   The abuse of opioids, including prescription painkillers and drugs like heroin, is something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release opioid painkillers such as oxycodone and fentanyl will have to carry a "black box" warning about the risk of abuse, addiction, overdose and death. Pfizer got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. In it, the oxycodone releases slowly over several hours. If the capsules are crushed, the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric effects. Pfizer also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!   A dietary supplement gets approved along with new forms of commonly used drugs    In 2016, Endoceutics got Intarosa, a once-daily vaginal insert, approved which is the first FDA approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA). Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Lisinopril, the most commonly used drug by U.S. Medicare patients, was approved as an Oral Solution for the first time.   Diabetes treatments, one of the most commonly prescribed drug categories in the U.S., saw the addition of Sanofi and Novo Nordisk’s fixed-dose, long-acting insulin and glucagon-like peptide 1 (GLP-1) agonist combinations to the list of options available to treat adult type-2 diabetes.  Our View   The approval of new drugs ensures that the world has access to improved healthcare solutions and breakthrough medical therapies. With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug approval scenario will be shaken up for time to come. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!    

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    https://www.pharmacompass.com/radio-compass-blog/fda-s-2016-approvals-of-new-drugs-formulations-strengths-more

    #PharmaFlow by PHARMACOMPASS
    09 Feb 2017
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    U.S. celebrity Kim Kardashian’s social media posts violate regulations, FDA issues warning letter

    U.S. celebrity Kim Kardashian’s social media posts violate regulations, FDA issues warning letter

    Kim Kardashian who is a model, actress, entrepreneur, socialite and star of the reality show ‘Keeping Up With The Kardashians’, has her posts on social media promoting the drug Diclegis, result in the US Food and Drug Administration (FDA) issuing a warning letter recently.The reality TV star shared a selfie of herself, on Instagram and Twitter, holding a bottle of Diclegis, a prescription-only drug used to treat nausea and vomiting during pregnancy. The posts violated FDA’s drug-promotion regulations and the warning letter was issued to Duchesnay USA, the company which produces the drug. The FDA’s warning letter said the media posts did not communicate the medical risks of the drug. Viral CommunicationKardashian’s posts, told over 40 million followers that Diclegis (doxylamine succinate and pyridoxine hydrochloride) made her feel “a lot better” and worked after everything else her doctor recommended had failed to cure her morning sickness. In addition she said, “Most importantly, it’s been studied and there was no increased risk to the baby”.“I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness…,” the post added, and was liked over 450,000 times. Kardashian’s post was pre-approved by Duchesnay, with whom Kardashian “partnered” to raise awareness about morning sickness.  What Kardashian failed to mention“The social media post is misleading because it presents various efficacy claims for DICLEGIS, but fails to communicate any risk information,” says the FDA warning letter. According to its FDA-approved product labeling, DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. The FDA also issued the warning letter for omitting material facts as the drug has not been studied in certain populations of women. Diclegis has not been studied in the about 1 percent of women who undergo dangerously severe vomiting called hyperemesis gravidarum, the condition that made headlines last year when in Britain, Prince William's wife Kate was briefly hospitalized.A different version of the drug, Benedictin was taken off the market in 1983 following a series of lawsuits alleging links to birth defects. The decision taken by Merrell Dow Pharmaceuticals, to stop selling Bendectin, was driven by commercial reasons because the company's insurance premiums had soared to US $ 10 million a year, only US $ 3 million less than the income from the sale of the drug. However, subsequent FDA investigations never established any link between the drug and the reported problems. All in the family The promotion was also a family affair. Duchesnay said Kardashian’s mother, Kris Jenner, also a paid spokeswoman, shared Kardashian’s social media posts on her own accounts. Jenner tweeted, "#SPONSORED Glad @KimKardashian is feeling better, wish I had something like this product during all my pregnancies! (sic)"As an expected corrective action, in the letter sent to the Executive Vice-President of Duchesnay, the FDA has mentioned that “corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated”.Diclegis has been available in Canada under the trade name Diclectin® for more than 30 years as the only prescription drug specifically indicated and approved for the management of nausea and vomiting of pregnancy (NVP). The product is a delayed-release combination of an old antihistamine and a form of vitamin B6 (doxylamine succinate and pyridoxine hydrochloride) designed to help women take a daily dose before their nausea sets in.Thankfully, the 34-year-old Keeping Up With the Kardashians star's doctor had prescribed her Diclegis. Although the FDA may not be happy about the posts, the advertisements have been a resounding success. AdWeek assessed the controversy will help the company in the long run, since more people have now heard of Diclegis.  

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    https://www.pharmacompass.com/radio-compass-blog/u-s-celebrity-kim-kardashian-s-social-media-posts-violate-regulations-fda-issues-warning-letter

    #Phispers by PHARMACOMPASS
    20 Aug 2015
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