Impavido, also known as miltefosine, is a significant drug in the treatment of leishmaniasis, a tropical disease caused by the Leishmania parasite. Here are the key points regarding its clinical trials and approval:
Clinical Trials
Impavido's safety and efficacy were evaluated in four clinical trials involving a total of 547 patients who received the drug, and 183 patients who received either a comparator drug or a placebo. These trials demonstrated that Impavido is safe and effective in treating visceral, cutaneous, and mucosal leishmaniasis[1][4].
- Visceral Leishmaniasis: One Phase 3 trial conducted in India involved 299 patients who received Impavido at a target dose of 2.5 mg/kg/day for 28 days. The trial showed a statistically significant higher percentage of patients achieving cure rates compared to those receiving amphotericin B deoxycholate[4].
- Cutaneous Leishmaniasis: A placebo-controlled trial evaluated the efficacy of Impavido in treating cutaneous leishmaniasis. The trial involved 89 patients receiving Impavido and 44 patients receiving a placebo, showing significant efficacy of Impavido in treating this form of the disease[4].
FDA Approval
The U.S. Food and Drug Administration (FDA) approved Impavido in 2014 for the treatment of visceral, cutaneous, and mucosal leishmaniasis. This approval marked the first FDA-approved drug for treating cutaneous or mucosal leishmaniasis. Impavido was granted fast track designation, priority review, and orphan product designation due to its potential to fill an unmet medical need in a serious disease or condition[1].
Postmarketing Commitments
As part of the approval, the FDA required several postmarketing studies, including:
- A study to evaluate the effects of Impavido on pregnancy outcomes for 10 years after approval.
- A study to evaluate the effects of Impavido on spermatogenesis and male hormones.
- A dedicated QT study to evaluate the effects of Impavido on the QT interval.
- A descriptive study regarding efficacy outcomes and adverse reactions in patients weighing more than 75 kg[3].
Safety and Side Effects
The clinical trials identified several common side effects associated with Impavido, including nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness, and elevated levels of liver enzymes and creatinine. The drug also carries a boxed warning due to its potential to cause fetal harm, and women are advised to use effective contraception during and for five months after therapy[1][4].
Market Analysis and Projections
Market Size and Growth
The leishmaniasis treatment market, which includes Impavido, is projected to experience significant growth.
- Current Market Size: The global leishmaniasis treatment market was valued at USD 95 million in 2021 and is projected to reach USD 167.62 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.0%[5].
- Forecasted Growth: Another report forecasts the market to grow from USD 124.4 million in 2020 to USD 237.7 million by 2028, at a CAGR of 8.4%[2].
Market Segmentation
The market is segmented based on disease type, pathological tests, therapy type, end-users, and region.
- End-Users: Hospitals and clinics held the largest market share in 2019, with a projected growth rate of 8.3% during the forecast period. The home care segment is growing at the highest CAGR of 11.2% due to the increasing demand for home and remote monitoring[2].
Regional Analysis
- North America: This region had the largest market share in 2019, driven by factors such as unhealthy lifestyles, a high number of chronic diseases, and government regulations related to healthcare development[2].
- Asia Pacific: This region is expected to grow with the highest CAGR during the forecast period, driven by strategic initiatives to improve healthcare infrastructure and increasing awareness about available treatments in developing countries like China and India[2].
Key Players
The market includes several key players:
- Paladin Labs Inc.: The manufacturer of Impavido, which received a Tropical Disease Priority Review Voucher under the FDA Amendments Act of 2007[1].
- Other Players: Sanofi S.A., Sequus Pharmaceuticals Inc., Enzon Pharmaceuticals Inc., Profounda, Inc., Gland Pharma Limited, Gilead Life sciences, and Lifecare Innovations Private Limited are also significant players in the market[2].
Key Takeaways
- Clinical Efficacy: Impavido has demonstrated safety and efficacy in treating visceral, cutaneous, and mucosal leishmaniasis through multiple clinical trials.
- Market Growth: The leishmaniasis treatment market is projected to grow significantly, driven by increasing awareness of healthcare and rising pathological treatments.
- Regional Trends: North America currently holds the largest market share, while the Asia Pacific region is expected to grow at the highest CAGR.
- Side Effects and Safety: Impavido has several common side effects and carries a boxed warning regarding its potential to cause fetal harm.
FAQs
What is Impavido used for?
Impavido (miltefosine) is used to treat visceral, cutaneous, and mucosal leishmaniasis, a tropical disease caused by the Leishmania parasite.
What were the key findings of the clinical trials for Impavido?
Clinical trials demonstrated that Impavido is safe and effective in treating the three main types of leishmaniasis, with significant cure rates compared to other treatments.
What are the common side effects of Impavido?
Common side effects include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, itching, drowsiness, and elevated levels of liver enzymes and creatinine.
What is the projected growth of the leishmaniasis treatment market?
The market is projected to grow from USD 124.4 million in 2020 to USD 237.7 million by 2028, at a CAGR of 8.4%.
Which regions are expected to drive the growth of the leishmaniasis treatment market?
North America currently holds the largest market share, while the Asia Pacific region is expected to grow at the highest CAGR during the forecast period.
Sources
- FDA Approves Impavido to Treat Tropical Disease Leishmaniasis - FierceBiotech
- Leishmaniasis Treatment Market Demand, Share 2020-2028 - Reports and Data
- 204684Orig1s000 - accessdata.fda.gov
- IMPAVIDO (miltefosine) capsules, for oral use - accessdata.fda.gov
- Leishmaniasis Treatment Market Size, Share, Trend, 2032 - Business Research Insights
