FDA Update: November 2016

Nov 1, 2016
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.
  • Hepatitis C
  • Inflammatory Conditions
  • Cancer

New Pill Bottle

The Emerging Therapeutics group monitors new drug approvals, new generics and other pharmaceutical developments in the U.S. Some important actions over the last month include:

MedWatch Update: Direct-Acting Antivirals

The U.S. Food and Drug Administration (FDA) is requiring a boxed warning to be added to the labeling and Medication Guides of direct-acting antiviral (DAA) drugs, which are used to treat chronic hepatitis C. On Oct. 4, 2016, the FDA released a Safety Communication warning that hepatitis B may return or be worsened for patients who take a DAA and who have or who have had hepatitis B. Between late November 2013 and mid-July 2016, FDA documented over 20 cases of hepatitis B that was reactivated by a DAA. Three of the cases were severe – resulting in a liver transplant or death. Before starting treatment for hepatitis C, patients should let their doctors know if they also have or had hepatitis B. Additionally, patients taking a DAA should immediately report symptoms, such as extreme fatigue, light-colored stools, loss of appetite, nausea, vomiting and yellowed eyes or skin, that could indicate liver damage from reactivated hepatitis B. Healthcare providers are advised to test hepatitis C patients for hepatitis B, as well. All DAAs will carry the new warning. Those currently approved in the U.S., are Daklinza (daclatasvir), Epclusa® (sofosbuvir/velpatasvir), Harvoni® (sofosbuvir/ledipasvir), Olysio® (simeprevir), Technivie® (ombitasvir/paritaprevir/ritonavir), Viekira® Pak and Viekira XR (dasabuvir/ombitasvir/paritaprevir/ ritonavir) and Zepatier (elbasvir/grazoprevir). For more information about the new warning, click here.

First Vagifem Generic Launched

Yuvafem® (estradiol vaginal inserts), the first generic for Novo Nordisk’s Vagifem® was released in the U.S. by Amneal Pharmaceuticals on Oct. 17, 2016. Each intravaginal insert contains a low dose of estradiol intended to treat atrophic vaginitis (dryness, irritation, itching and pain) after menopause. Dosing is one insert per day for the first two weeks, then two inserts per week spaced about three days apart. Yuvafem will be dispensed in packages of eight and 18 inserts – each in a disposable applicator. Its labeling carries boxed warnings common to all estrogens. Used alone, it may raise the risk of breast or endometrial cancers, blood clots or strokes. When used along with a progestin, estrogens may contribute to cardiovascular conditions and possibly to dementia. IMS Health estimates that sales of Vagifem totaled $423 million for the 12-month period ending Jul. 31, 2016.

Inflectra to Launch in Late November

On Oct. 17, 2016, Pfizer announced that it will launch Inflectra (infliximab-dyyb), a biosimilar to Janssen’s Remicade®, in late November, pending FDA approval. Inflectra was approved on Apr. 5, 2016, for all Remicade-approved indications, except pediatric ulcerative colitis. It will be used for treating patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease. Inflectra, a tumor-necrosis factor (TNF) blocker, was the first biosimilar monoclonal antibody to gain FDA approval. Based on the wholesale acquisition cost (WAC), Inflectra will be priced at a 15% discount to Remicade. Sandoz’s Erelzi (etanercept – szzs), a biosimilar to Amgen’s Enbrel®, and Amgen’s Amjevita (adalimumab – atto), a biosimilar to AbbVie’s Humira® are additional TNF blocker biosimilars that have been FDA approved. The launch of Erelzi and Amjevita could be delayed for two or more years due to patent litigation.

Tecentriq Approved for Lung Cancer

On Oct. 18, 2016, Genentech’s Tecentriq™ (atezolizumab) was approved by the FDA to treat patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Tecentriq is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. It is an immunotherapy that helps the body’s immune system attack cancer cells. Tecentriq was originally approved on May 18, 2016, for the second-line treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC). The recommended dose of Tecentriq for NSCLC and mUC is 1200mg as an intravenous infusion over 60 minutes once every three weeks. Full prescribing information can be found here.

Lilly Receives Approval for Lartruvo

Lartruvo™ (olaratumab injection, 10mg/mL – Eli Lilly and Company) received FDA approval on Oct. 19, 2016. It is the first monoclonal antibody to be indicated for treating adults with soft tissue sarcomas (STS) that have histologic subtypes appropriate for an anthracycline-containing regimen, but that are not amenable to curative treatment with radiation or surgery. Recommended dosing for Lartruvo is on 21-day cycles with 15mg/Kg given as a 60-minute intravenous (IV) infusion on the first and eighth days. Doxorubicin is given along with Lartruvo for the first eight cycles. Treatment continues until the patient can no longer tolerate side effects or until the cancer ceases to respond. In the open-label, phase II JGDG clinical trial, median overall survival was nearly one year longer among patients using Lartruvo and doxorubicin than among patients on doxorubicin alone. Full prescribing information can be found here.

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