Tag Archives: fda

US FDA Approves MOVANTIK™ (naloxegol) Tablets C-II

On September 16, the US Food and Drug Administration approved MOVANTIK™ (naloxegol) tablets C-II as the first once-daily oral peripherally acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Movantik_US_CII_TM_5COpioids play an important role in chronic pain relief by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract. That is why patients taking opioids for chronic pain can develop OIC.

For patients who take opioids for chronic pain, constipation is one of the most common side effects, which can continue throughout their pain management therapy.  

MOVANTIK is expected to be available by prescription in pharmacies nationwide in the first half of 2015.

MOVANTIK strengthens AstraZeneca’s existing portfolio of medicines and aligns with our strategic focus on scientific leadership. AstraZeneca is dedicated to filling an unmet need for adult patients taking prescription opioids for chronic non-cancer pain who are experiencing OIC not adequately relieved by laxatives. It reflects our ongoing commitment to developing treatment options and supporting health care providers, patients and caregivers.

Important Safety Information for MOVANTIK

  • MOVANTIK is contraindicated in:
    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction due to the potential for GI perforation
    • Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
    • Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
  • Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone in the clinical trials were observed to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients.
  • The most common adverse reactions with MOVANTIK in clinical trials were: abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)

Please see full US Prescribing Information


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088

3026008 Last Updated 9/14


US FDA Approves EPANOVA® (omega-3 carboxylic-acids)

By Rod Wooten, Executive Director, AstraZeneca



AstraZeneca recently announced that the US Food and Drug Administration (FDA) approved EPANOVA® (omega-3-carboxylic acids) as an adjunct to diet to lower triglyceride levels in adults with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500 mg/dL).

Triglycerides are a type of lipid (fat) found in blood and an essential energy source for the body. Some people have severely high triglyceride levels, meaning they have too much fat in their blood, and that can lead to serious health complications.  Nearly four million American adults currently have severe hypertriglyceridemia and this figure continues to increase along with the incidence of associated conditions, such as obesity and diabetes.

EPANOVA is the first FDA-approved prescription omega-3 in free fatty acid form. The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day. It can be taken with or without food.

EPANOVA strengthens AstraZeneca’s existing portfolio of medicines and aligns with our strategic focus on scientific leadership. It reflects our ongoing commitment to developing treatment options and supporting health care providers, patients and caregivers.

EPANOVA® (omega-3-carboxylic acids)
Indication and Important Safety Information

EPANOVA is a prescription medicine used along with a low fat and low cholesterol diet to lower very high triglyceride (fat) levels in adults.

It is not known if EPANOVA changes your risk of having inflammation of your pancreas (pancreatitis).

It is not known if EPANOVA prevents you from having a heart attack or stroke.

Important Safety Information for EPANOVA® (omega-3-carboxylic acids) Capsules

  • Do not take EPANOVA if you are allergic to omega-3-carboxylic acids or any of the ingredients in EPANOVA
  • Tell your doctor if you are allergic to fish or shellfish, or if you are pregnant, breastfeeding or plan to become pregnant or breastfeed, as EPANOVA may not be right for you
  • Talk to your doctor about any current medical conditions you have and any medications you are taking, including prescription and over the counter medications, vitamins, and herbal supplements
  • Take EPANOVA exactly as your doctor tells you to take it and do not change your dose or stop taking EPANOVA without talking to your doctor
  • Your doctor should do blood tests to check your triglycerides, bad cholesterol (LDL-C) and liver function while you take EPANOVA
  • EPANOVA may cause serious side effects including increases in blood tests for liver function (ALT and AST) and for bad cholesterol (LDL-C), and possible allergic reactions if you are also allergic to fish or shellfish
  • The most common side effects of EPANOVA are diarrhea, upset stomach, abdominal pain or discomfort, and burping

Please see full Prescribing Information

2985606 Last Updated 5/14


FDA receives critical funding for 2012

AstraZeneca and the Alliance for a Stronger FDA applaud members of the House and Senate for providing FDA with $2.5 billion in funding for 2012—an increase of $50 million.

AstraZeneca advocates for a strong, well-funded FDA so that it can protect Americans’ health.

Alliance President Nancy Bradish Myers summarizes why a well-funded FDA is so important:

“FDA must continue to be a national priority so that we can advance medical progress, improve patients’ lives, and assure Americans have a safe food supply.”

According to the Alliance, a strong FDA supports the economy, as FDA oversees nearly 25 percent of all consumer spending.

“Multiple times every day, Americans use products for which FDA has oversight responsibilities. There is no back-up if the agency isn’t there,” said Diane Dorman, an Alliance board member.

“FDA’s job is much like national defense—essential to our nation’s well-being—and providing protection that is too often taken for granted until a crisis occurs,” added Richard Buckley, an Alliance Board Member and Vice President, Federal Government Affairs, AstraZeneca. “A strong FDA is welcomed by the industries it oversees and spurs innovation that drives our economy.”

For more information on what makes a strong FDA, click here.

Why patents matter

The principal economic safeguard in our industry is a well-functioning patent system that recognizes our effort and rewards our innovation with appropriate protection.

We have blogged quite a bit about U.S. patent reform but wanted to provide context on why patents and other forms of intellectual property are important to the biopharmaceutical industry.

First, what is a patent?

A patent provides the right to exclude others from making, using, selling, offering for sale, or importing the patented invention for the term of the patent, usually 20 years from the filing date.

Why do patents matter to our industry?

The discovery and development of a new medicine requires a significant investment of resources by research-based pharmaceutical companies over a period of 10 or more years (click here for an interactive look at the process).

Biopharmaceutical companies often file for a patent on a promising research project early on in this process, meaning that the patent term begins long before a potential new medicine gets to market. In fact, patents can be expired before drug approval, issued after drug approval, and anywhere in between.

For this to be a viable investment, the results – new medicines – must be safeguarded from being copied with a reasonable amount of certainty for a reasonable period of time so the industry can generate the revenue it needs to reinvest in new medicines.

Are patents the only form of intellectual property protection for medicines?

Regulatory Data Protection (or ‘data exclusivity’) is an important intellectual property right concerning data we are required to submit to regulatory authorities in order to obtain marketing approvals for our medicines. Significant investment is required to generate such data (for example, through conducting global clinical trials); and this proprietary data is protected from use by third parties (such as generic manufacturers) for a number of years in a limited number of countries. The period of such protection and the extent to which the right is respected differs significantly between these countries.

This FDA fact sheet on patents and data exclusivity explains that in the US, data exclusivity represents exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Data exclusivity is designed to promote a balance between new drug innovation and generic drug competition.

Where can I learn more?

For more information, visit the Coalition for 21st Century Patent Reform at http://www.patentsmatter.com.