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Ahead of the Curve, FDA Approves 35 Innovative Drugs in FY2011


The US Food and Drug Administration (FDA) has released a report entitled “FY2011 Innovative Drug Approvals” highlighting the accomplishments of the agency this fiscal year which ended on September 30. Thirty-five new medications for diseases including hepatitis C, prostate cancer, Hodgkin’s lymphoma and lupus have been approved, many ahead of other countries.

The US FDA is an agency within the US Department of Health and Human Services that protects the public health by assuring the safety, effectiveness and security of both human and veterinary drugs, vaccines, and medical devices.

The report details how the agency used expedited approval authorities, flexibility in clinical trial requirements, and resources collected under the Prescription Drug User Fee Act (PDUFA). Although the FDA is approving drugs faster than its counterparts around the world, including the European Union, safety standards have been maintained. Almost 70% of the drugs approved were done before any other country in the world.

"Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients," said Margaret Hamburg, M.D., Commissioner of Food and Drugs. "We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."

Among the new drugs approved, seven provide major advances in cancer treatment. Ten drugs are for rare (“orphan”) diseases which have few or no treatments because of their small patient population. Among the most notable approvals are:

Zytiga (albiraterone acetate) for late-stage prostate cancer
Zytiga was shown to prolong the survival by almost 4 months in certain late-state prostate cancer patients, whose cancer is “castration-resistant.” The drug was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs.

Zelboraf (vemurafenib) for melanoma
Zelboraf is the first of a new class of drugs to treat patients with metastatic or unresectable melanoma, the most dangerous type of skin cancer. The drug is specifically indicated for the treatment of patients whose tumors express a gene mutation called BRAF V600E.

Xalkori (crizotinib) for lung cancer
Xalkori is the first in a new class of drugs that targets the abnormal ALK gene that contributes to the development of lung cancer. The medication was approved with a companion genetic test to allow the treatment to be targeted toward the patients it is most likely to help.

Yervoy (ipilimumab) for late-stage melanoma
Yervoy is also in a new class of medications called immune-boosting drugs. It has been shown to prolong survival in patients with metastatic melanoma. Yervoy was also approved under the FDA’s priority review program.

Adcetris (brentuximab vedotin) for two types of lymphoma
Adcetris is the first FDA-approved treatment for Hodgkin’s lymphoma since 1977 and the first specifically indicated to treat a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Accelerated approval was granted with a commitment by the company to provide additional data after the approval of the drug.

Caprelsa (vandetanib) for thyroid cancer
Caprelsa treats medullary thyroid cancer, for which there has been no other FDA-approved treatments. Patients who received the drug had a longer period of time without disease progression when compared to patients receiving a placebo.

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Halaven (eribulin mesylate) for metastatic breast cancer
Halaven is approved to treat breast cancer patients whose cancer has spread and who have already been treated with at least two other chemotherapeutic regimens. In a trial, patients treated with Halaven lived 2.5 months longer than those treated with an alternative therapy.

Victrelis (boceprevir) for chronic Hepatitis C
Patients given Victrelis with two other drugs (pegylated interferon and ribavirin) had an increased sustained virologic response against the Hep C virus, meaning it is no longer detectable in the patient’s blood. This can result in decreased cirrhosis and complications of liver disease.

Incivek (teleprevir) for chronic Hepatitis C
Incivek is a protease inhibitor in the same class as Victrelis. The two drugs were approved within 10 days of each other under the priority review program.

Benlysta (belimumab) for systemic lupus
Benlysta was the first new treatment for lupus in over 50 years. It is in a new class of drugs which reduces disease activity and the likelihood of a severe “flare.”

Pradaxa (dabigatran etexilate) for reducing the risk of stroke
Pradaxa is the first oral anticoagulant drug approved since warfarin (Coumadin) in the 1950-‘s to prevent blood clots and stroke in patients with abnormal heart rhythm (atrial fibrillation). One benefit of Pradaxa over warfarin is that patients are not required to undergo periodic monitoring with blood tests.

Brilinta (ticagrelor) for reducing cardiovascular death and heart attack
Brilinta was shown in clinical trials to reduce the risk of cardiovascular death and heart attack in patients with acute coronary syndromes (ACS), which include unstable angina, better than Plavix. Brilinta prevents the formation of new blood clots, thus maintaining blood flow.

Teflaro (ceftaroline fosamil) for the treatment of bacterial skin infections and pneumonia
Teflaro is an injectable antibiotic which is approved to treat skin infections such as MRSA which is resistant to other drugs.

Nulojix (belatacept) for prevention of rejection of transplanted kidneys
Nulojix belongs to a new class of primary immunosuppressants preventing acute organ rejection in adult kidney transplant patients. The drug works with other immunosuppressants to control the immune system and keep the new kidney working.

Firazyr for the treatment of acute attacks of hereditary angioedema (HAE)
HAE is a rare disease caused by low levels or the improper function of the C1 inhibitor which normally is involved in regulating certain immune system and blood clotting pathways. Firazyr is only the third drug approved in the US for the treatment of HAE attacks.

Corifact (Factor XIII Concentrate) for the prevention of bleeding in patients with congenital Factor XIII deficiency
This rare clotting disorder affects only one out of every 3 to 5 million people in the United States. Without treatment, patients are at risk for life-threatening bleeding.

Anascorp for the treatment of clinical signs of scorpion envenomation
Anascorp is the first specific treatment approved in the US for scorpion stings which, if left untreated, can be life-threatening. The drug resolved symptoms in four hours in a clinical trial involving 15 children.

Source Reference: US Food and Drug Administration (FDA), “FY2011 Innovative Drug Approvals"