Is Nplate an orphan drug?
The spleen, an organ behind the stomach, is involved in the removal of platelets from the blood. Because the number of patients with ITP is low, the disease is considered ‘rare’, and Nplate was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 May 2005.
When was Nplate approved?
/node/373372On December 14, 2018, the Food and Drug Administration approved romiplostim (NPLATE, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Can orphan drug status be removed?
The sponsor of a designated orphan medicine can request removal of its orphan designation from the European Commission’s Community register of orphan medicinal products at any time.
Who invented romiplostim?
The drug was developed by Amgen through a restricted usage program called NEXUS. During development and clinical trials the drug was called AMG531. Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP).
What are the side effects of Nplate?
The most common side effects of Nplate® in adults include:
- joint pain.
- trouble sleeping.
- muscle tenderness or weakness.
- pain in arms and legs.
- stomach (abdomen) pain.
- shoulder pain.
How much does Nplate cost?
The cost for Nplate subcutaneous powder for injection 125 mcg is around $1,151 for a supply of 1 powder for injection, depending on the pharmacy you visit….Subcutaneous Powder For Injection.
Is nplate FDA approved?
(NASDAQ: AMGN) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nplate(TM) (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura …
What drug is FDA approved for in thrombocytopenia?
The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the first drug approved by the FDA for this use.
How long does orphan drug status last?
Key Takeaways Orphan drug status (designated by the FDA) gives a company exclusive marketing rights for a seven-year period, along with other benefits to recoup the costs of researching and developing drugs to treat rare diseases.
How long is orphan drug exclusivity?
The exclusivity granted to orphan drugs provides seven years without generic competition for the approved orphan designation but does not prevent generic competition for other approved uses of the medicine. Orphan exclusivity continues longer than patent protection in only 60 of the 503 orphan-designated medicines.
Is nplate a biologic?
Nplate basics Nplate contains the drug romiplostim, which is a biologic medication.