New, riveting trends in drug development have emerged as of late. Traditional drugs for the treatment of conditions such as diabetes or cardiovascular diseases are no longer the big focus for prescription pharmaceuticals. The wave of the future is biologics: drugs made from living organisms. These are specialty drugs that treat rare diseases and illnesses, such as multiple sclerosis and cancers. Motivated by government incentives, and in the hopes of reaching new markets and facing less competition after patents expire, manufacturers introduced highly specialized products in the past year. Here are some of the most notable recent prescription drugs that have come into the market.
1. Treatments for Multiple Sclerosis
Among the conditions that received the most attention, was multiple sclerosis. Two new drugs, Gilenya™, the first oral drug for Multiple Sclerosis (MS), and Ampyra®, the first to treat a symptom of MS, were released in 2010. Cladribine™, currently used for leukemia, is pending approval for the treatment of MS in 2011. A few others are currently in trials hoping to be completed by the end of the year.
2. Cancer Drug Developments
The fight against cancer continues with four new developments. For prostate cancer, a first time vaccine Provenge®, was introduced along with a second line agent, Jevtana®. Additionally, a lot of excitement in the healthcare world surrounds the new Xgeva™, which was shown to prevent bone metastasis in certain cancers. It was also released as Prolia™, a twice yearly injection for osteoporosis. With a 12% rate of breast cancer among women, the new Halaven for metastatic breast cancer, is a welcomed addition. This drug can be used to treat late-stage breast cancer in patients who have already taken two previous chemo regimes.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
3. Specialty Drugs
Several specialty drugs, and first time treatments for rare disorders, appeared in 2010. A notable one in this category is Egrifta™, to help treat lipodystrophy, a common side effect from HIV therapy. Also worth mentioning is Actemra, to help slow the progression of rheumatoid arthritis, Teflaro, a new broad-spectrum cephalosporin, and Krystexxa, the first biologic developed for gout.
4. Blood Anticoagulant Improvements
One of the biggest breakthroughs of 2010 was the new Pradaxa®. It is an anticoagulant for the prevention of stroke and blood clots in patients with abnormal heart rhythm or atrial fibrillation. Its efficacy is comparable to Warfarin (another anticoagulant that has been on the market since the early 50s) but it does not require the periodic labs and monitoring. Another competitor in this area, Xarelto®, is pending approval.
5. “Me Too” Drugs
The development of drugs in the same class as others already available, or “me too” drugs, was a big thing in the past. After seeing marginal clinical benefit in this category, there were only two contributions last year.
Latuda®, the tenth atypical antipsychotic for schizophrenia was introduced, and Victoza® for diabetes, which was in the same category as Byetta® (an injectable tube that may improve blood sugar levels).
An interesting new indication was seen with Kapvay™. Approved by the FDA in late 2010, this drug used for many years to treat blood pressure, it is now also indicated for ADHD.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
6. Geriatric Drug Developments
We are facing an aging population with multiple diseases, and multiple medications, which unavoidably leads to issues with compliance. Many new combination drugs are being developed to promote better adherence of patients to their drug regimens. Duexa®, Moxduo®, and Vimovo™ are some of the most recent ones developed.
What we can expect to see more of is the continued progress in the field of biologics. Although they offer very effective, brand new therapies and mechanisms in the treatment of many serious illnesses, they are not without significant immune-mediated side effects, and a very high cost for the patient. On the other end of the price spectrum, the generic market continues to flourish, giving patients some much needed financial relief. In our often unpredictable health care system, one thing we can rely on is a consistent supply of new and innovative drugs.
