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FDA Approves Seebri Neohaler

FDA Approves Seebri Neohaler (glycopyrrolate) for COPD

EAST HANOVER, N.J., Oct. 29, 2015 Novartis announced today that the US Food and Drug Administration (FDA) has approved Seebri Neohaler (glycopyrrolate) inhalation powder 15.6 mcg as a stand-alone monotherapy for COPD. Novartis expects that Seebri Neohaler will be available in the first quarter of 2016.

Seebri is delivered via the low resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.

About Seebri Neohaler

Seebri Neohaler, previously known as NVA237, is a twice-daily long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Glycopyrrolate (also known as glycopyrronium bromide) was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

About Novartis Respiratory

Novartis is committed to addressing patients' unmet needs in respiratory conditions with medicines like Xolair® (omalizumab) for injection, for subcutaneous use, and TOBI® Podhaler™ (tobramycin inhalation powder). The FDA approval of Utibron Neohaler is an example of how the company's research and development efforts in this area can lead to new options for patients.

INDICATION

Seebri Neohaler ia a prescription medicine used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Seebri is used long-term, inhaled twice a day, to improve symptoms of COPD for better breathing.

Seebri contains the anticholinergic glycopyrrolate. This medicine works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

Seebri is not used to treat sudden symptoms of COPD and won't replace a rescue inhaler.

IMPORTANT SAFETY INFORMATION

Call your doctor or get emergency medical care if your breathing problems worsen quickly, if you need to use your rescue inhaler more often than usual, or if you use your rescue inhaler medicine but it does not relieve your breathing problems. Call your doctor if breathing problems worsen over time while using Seebri.

Do not use Seebri Neohaler if you are allergic to glycopyrrolate or any of the ingredients in Seebri. Ask your doctor if you are not sure.

Do not swallow Seebri capsules. Only use Seebri capsules with the Neohaler inhaler. Never place a capsule in the mouthpiece of the Neohaler inhaler.

Tell your doctor about kidney problems, eye problems such as glaucoma, prostate problems, bladder problems, problems passing urine, or other medical conditions, including if you are pregnant, planning to become pregnant or breastfeeding, before using Seebri.

Tell your doctor if you are allergic to Seebri or any of their ingredients, any other medicines, or food products. Seebri contains lactose (milk sugar) and small amounts of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Using Seebri with other medicines may cause serious side effects. Tell your doctor if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate), because taking them together with Seebri can increase side effects.

Seebri may cause serious side effects, including life-threatening sudden shortness of breath immediately after use and serious allergic reactions including rash; hives; swelling of the tongue, lips, and face; difficulty breathing or swallowing. If you have any of these symptoms, stop taking Seebri and get immediate medical help.

Seebri can cause new or worsened eye problems, including acute narrow-angle glaucoma, which can cause permanent loss of vision if not treated. Symptoms may include: eye pain or discomfort, nausea or vomiting, blurred vision, seeing halos or bright colors around lights, or red eyes. If you have any of these symptoms, stop Seebri and call your doctor right away.

Seebri can cause new or worsened urinary retention. Symptoms of urinary retention may include: difficulty urinating, painful urination, urinating frequently, or urination in a weak stream or drips. If you have these symptoms, stop taking Seebri and call your healthcare provider right away.

Common side effects of Seebri include upper respiratory tract infection, sore throat, and runny nose.

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

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "expect," "will," "can," "committed," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Seebri Neohaler, or regarding potential future revenues from any or all of the products in the Novartis respiratory portfolio, including Seebri Neohaler. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Seebri Neohaler will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that any of the products in the Novartis respiratory portfolio will receive additional regulatory approvals or be commercially successful in the future. In particular, management's expectations regarding these products could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing or quality issues; unexpected safety issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients' lives. We offer a broad range of medicines for cancer, cardiovascular disease, endocrine disease, inflammatory disease, infectious disease, neurological disease, organ transplantation, psychiatric disease, respiratory disease and skin conditions. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion, excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com. Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

SOURCE Novartis Pharmaceuticals Corporation

Posted: October 2015

Seebri Neohaler (glycopyrrolate) FDA Approval History

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