Natpara to be distributed through select group of specialty pharmacies and supported by comprehensive patient support services
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that Natpara® (parathyroid hormone) for injection is now available in the United States. The U.S. Food and Drug Administration (FDA) approved Natpara as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism on January 23, 2015. Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute post-surgical hypoparathyroidism.
Natpara will be available through a Risk Evaluation and Mitigation Strategy (REMS) Program and a limited network of specialty pharmacies. Eligible patients who are prescribed Natpara will have access to patient support services through NPS Advantage. These services include access to NPS Advantage Care Coordinators who can provide: information about Natpara, insurance authorization, appeals and financial assistance; assistance with ordering products; and, connect patients with a Nurse Educator.
“We are proud to introduce Natpara because it fulfills a long-term unmet need for a subset of an already rare patient population who cannot be well-controlled on the standard of care, and until now, did not have an FDA-approved parathyroid hormone to help treat their condition,” said Roger Adsett, Head of the Gastrointestinal and Internal Medicines Business Unit at Shire. “The Natpara launch is an example of how we are addressing a significant unmet patient need and expanding our rare disease offerings.”
Natpara may cause serious side effects, including possible bone cancer (osteosarcoma). During animal drug testing, Natpara caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take Natpara will have a higher chance of getting osteosarcoma. See below for additional Important Safety Information and full prescribing information about Natpara.
Because of the potential risk of osteosarcoma associated with Natpara therapy, Natpara is available only through a restricted REMS program called the Natpara REMS Program. Under the Natpara REMS Program, only certified healthcare providers can prescribe and only certified pharmacies can dispense Natpara. Further information is available at www.NATPARAREMS.com or by telephone at 1-855-NATPARA.
It is not known if Natpara is safe and effective for children 18 years of age or younger. Natpara should not be used in children and young adults whose bones are still growing.
In Europe, the European Medicines Agency (EMA) has validated and initiated its review of the company’s marketing authorization application for Natpar™.
NPS Advantage is a patient support program for eligible patients prescribed Natpara. At no charge, NPS Advantage Care Coordinators can provide: information about Natpara, insurance authorization, appeals and financial assistance; assistance with ordering products; and, connect patients with a Nurse Educator. More information about services for people prescribed Natpara can be found at NPSAdvantage.com or by speaking with a Care Coordinator. Shire offers a co-pay assistance program for eligible patients. Patients who are uninsured or have limited insurance coverage may be eligible to receive treatment through the Natpara Patient Assistance Program.
Natpara® (parathyroid hormone) for injection is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Natpara is a bioengineered replica of human parathyroid hormone. Natpara is self-administered once daily by subcutaneous injection.
Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations or in patients with acute post-surgical hypoparathyroidism.
In clinical studies, Natpara has been shown to help maintain serum calcium levels while reducing the need for oral calcium and active vitamin D and, in some cases, eliminate the need for active vitamin D altogether. The most common adverse reactions associated with Natpara and occurring in greater than 10% of individuals were: paresthesia, hypocalcemia, headache, hypercalcemia, nausea, and hypoesthesia, diarrhea, vomiting, arthralgia, hypercalciuria and pain in extremity.
Natpara is available in four dosage strengths: 25 mcg, 50 mcg, 75 mcg, and 100 mcg.
Natpara received orphan drug status for the treatment of hypoparathyroidism from the FDA in 2007 and the EMA in 2013.
NATPARA may cause serious side effects, including:
Possible bone cancer (osteosarcoma).
High blood calcium (hypercalcemia)
Low blood calcium (hypocalcemia)
Tell your doctor right away if you have any of these signs and symptoms of high or low blood calcium levels.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
NATPARA and other medicines may affect each other causing side effects.
Especially tell your doctor if you are taking medicines that contain digoxin, alendronate, calcium supplements or food products that contain calcium, or active Vitamin D.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist each time you get a new medicine.
These are not all the possible side effects of NATPARA. For more information, ask your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the NPS Adverse Event/Product Complaint Line at 1-855-215-5550 or by calling the Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
and other risks and uncertainties detailed from time to time in Shire’s filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
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